Incident: Cardiac Pacemaker Data Reporting Failure due to Battery Malfunction

Published Date: 2016-10-28

Postmortem Analysis
Timeline 1. The software failure incident involving the Nanostim leadless cardiac pacemaker (LCP) happened between 29 and 37 months after implant [48755]. 2. The article was published on 2016-10-28. 3. Estimation: - The incident occurred between March and November 2014.
System 1. Nanostim leadless cardiac pacemaker (LCP) [48755]
Responsible Organization 1. St. Jude Medical Inc was responsible for causing the software failure incident with its Nanostim leadless cardiac pacemaker due to a battery malfunction [48755].
Impacted Organization 1. Patients with Nanostim leadless cardiac pacemakers implanted by St. Jude Medical Inc were impacted by the software failure incident [48755].
Software Causes 1. The software cause of the failure incident was a battery malfunction leading to problems with electronic data reporting in the Nanostim leadless cardiac pacemaker [48755].
Non-software Causes 1. Battery malfunction in the Nanostim leadless cardiac pacemaker (LCP) causing electronic data reporting problems [48755] 2. Risk of premature battery depletion in other implanted heart devices (ICDs and CRT-Ds) leading to a recall [48755]
Impacts 1. The software failure incident with the Nanostim leadless cardiac pacemaker (LCP) caused problems with electronic data reporting due to a battery malfunction, potentially putting patients at risk [48755]. 2. St. Jude Medical Inc had to notify doctors to stop implants of the affected pacemakers, leading to a halt in the implantation of Nanostim devices [48755]. 3. Out of 1,423 Nanostim devices implanted worldwide, 1,397 remained in service, posing a potential risk to patients [48755]. 4. The company recommended device replacement for affected patients, with priority given to those with implants of the longest duration [48755]. 5. St. Jude Medical Inc faced challenges in managing the situation and ensuring that physician partners worldwide had the necessary information to handle their patients effectively [48755].
Preventions 1. Implementing rigorous testing procedures during the development phase to detect any potential electronic data reporting issues caused by battery malfunctions [48755]. 2. Conducting thorough risk assessments and quality assurance checks on the Nanostim leadless cardiac pacemaker (LCP) before widespread implantation to identify and address any vulnerabilities [48755]. 3. Regularly monitoring and analyzing telemetry data from implanted devices to proactively detect and address any anomalies or malfunctions before they pose a risk to patients [48755]. 4. Ensuring timely communication and collaboration with healthcare providers to promptly address any reported problems or concerns related to the functionality of the pacemakers [48755].
Fixes 1. Implement a software update or patch to address the electronic data reporting problems caused by the battery malfunction in the Nanostim leadless cardiac pacemaker [48755].
References 1. St. Jude Medical Inc 2. Abbott Laboratories 3. St. Jude Chief Medical Officer Mark Carlson 4. New York Stock Exchange 5. Reuters 6. Patients affected by the malfunction 7. Doctors who received the letter from St. Jude 8. Patients who received replacement devices 9. European incidents related to premature battery depletion 10. ICDs and CRT-Ds affected by the recall 11. St. Jude shares information 12. Brendan McDermid (Photographer for the image in the article) [48755]

Software Taxonomy of Faults

Category Option Rationale
Recurring one_organization (a) The software failure incident related to St. Jude Medical's cardiac pacemakers is an example of a similar incident happening again within the same organization. The article mentions that the Nanostim leadless cardiac pacemaker (LCP) issue is not the first problem with St. Jude heart devices. Earlier in the article, it is stated that the company had announced a recall of some of its other implanted heart devices due to the risk of premature battery depletion, which was linked to two deaths in Europe. This indicates a pattern of software-related issues with St. Jude Medical's products [48755].
Phase (Design/Operation) design, operation (a) The software failure incident related to the design phase can be inferred from the article. St. Jude Medical Inc reported problems with electronic data reporting caused by a battery malfunction in their Nanostim leadless cardiac pacemaker (LCP) [48755]. This issue indicates a failure in the design phase where contributing factors introduced during the development of the system led to problems with data reporting and telemetry. (b) The software failure incident related to the operation phase is also evident in the article. St. Jude Medical Inc instructed doctors to stop implants of the Nanostim pacemakers due to reports of lost telemetry and heart pacing output from the devices [48755]. This issue points to a failure in the operation phase where contributing factors introduced by the operation or misuse of the system led to potential risks for patients.
Boundary (Internal/External) within_system (a) within_system: The software failure incident related to the St. Jude Medical cardiac pacemakers was primarily within the system. The failure was caused by a battery malfunction leading to problems with electronic data reporting, specifically lost telemetry and heart pacing output from the devices [48755]. The issue was related to the internal functioning of the pacemakers themselves, indicating a within-system failure.
Nature (Human/Non-human) non-human_actions, human_actions (a) The software failure incident related to non-human actions in this case is due to a battery malfunction in the Nanostim leadless cardiac pacemaker (LCP) manufactured by St. Jude Medical Inc. The malfunction caused problems with electronic data reporting, leading to lost telemetry and heart pacing output from the devices, putting patients at risk [48755]. (b) The software failure incident related to human actions in this case involves the decision made by St. Jude Medical Inc to notify doctors to stop implants of the affected pacemakers and to recommend device replacement. Additionally, the company is working to ensure physicians have the necessary information to manage their patients effectively, indicating human intervention in response to the software failure incident [48755].
Dimension (Hardware/Software) hardware (a) The software failure incident related to hardware: - The article mentions that the software failure incident with the Nanostim leadless cardiac pacemaker (LCP) was caused by a battery malfunction, which is a hardware issue [48755]. (b) The software failure incident related to software: - The article does not specifically mention any software-related contributing factors that led to the failure incident. Therefore, it is unknown if the failure originated in the software [48755].
Objective (Malicious/Non-malicious) non-malicious (a) The software failure incident related to the St. Jude Medical cardiac pacemakers was non-malicious. The failure was attributed to a battery malfunction causing problems with electronic data reporting, leading to lost telemetry and heart pacing output from the devices. St. Jude Medical notified doctors to stop implants of the affected pacemakers to prevent potential risks to patients [48755].
Intent (Poor/Accidental Decisions) unknown The software failure incident reported in Article 48755 is related to a cardiac pacemaker malfunction caused by a battery issue, leading to problems with electronic data reporting. This incident does not directly point to poor decisions or accidental decisions related to software development or implementation. Instead, the failure seems to be primarily attributed to a technical issue with the pacemaker device itself.
Capability (Incompetence/Accidental) accidental (a) The software failure incident related to development incompetence is not explicitly mentioned in the provided article [48755]. (b) The software failure incident related to an accidental factor is evident in the article as it mentions problems with electronic data reporting caused by a battery malfunction in the Nanostim leadless cardiac pacemaker. This issue was not intentional but occurred accidentally, leading to potential risks for patients [48755].
Duration temporary The software failure incident reported in the article is related to a temporary failure caused by a battery malfunction in the Nanostim leadless cardiac pacemaker (LCP) manufactured by St. Jude Medical Inc. The article mentions that there were reports of problems with electronic data reporting caused by the battery malfunction, leading to lost telemetry and heart pacing output from the devices [48755]. The issue occurred between 29 and 37 months after implant, indicating a specific timeframe for the failure to manifest. Additionally, the company recommended device replacement for affected patients, with priority given to those with implants of the longest duration, suggesting a temporary nature of the failure that can be addressed through device replacement [48755].
Behaviour crash (a) crash: The software failure incident related to the St. Jude Medical cardiac pacemakers can be categorized as a crash. The article mentions that there were reports of problems with electronic data reporting caused by a battery malfunction, leading to lost telemetry and heart pacing output from the devices [48755]. This indicates a failure of the system to perform its intended functions due to a crash, where the system lost its state and could not carry out its functions properly.

IoT System Layer

Layer Option Rationale
Perception None None
Communication None None
Application None None

Other Details

Category Option Rationale
Consequence death, harm, non-human (a) death: The article mentions a recall of some of St. Jude's implanted heart devices due to the risk of premature battery depletion, which was linked to two deaths in Europe [48755].
Domain manufacturing, health (a) The failed system was related to the health industry. The incident involved a software failure in a cardiac pacemaker manufactured by St. Jude Medical Inc, a medical device maker [48755]. The affected device, the Nanostim leadless cardiac pacemaker, experienced problems with electronic data reporting caused by a battery malfunction, which could put patients at risk. The company notified doctors to stop implants of this pacemaker due to the reported issues.

Sources

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