INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR 2, VENTAK PRIZM 2 VITALITY, VITALITY 2 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2006/038

CON2024060

2006-07-13

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2024060

Recall due to component failure. guidant has informed mhra that a sub-set of the implantable pacemaker/defibrillators listed above may suffer degradation of a high-stability low-voltage capacitor leading to device malfunction or premature battery depletion. prevalence of device malfunction in the future and the mean time to failure have not yet been established. contaminated material used in the manufacturing process of a low-voltage capacitor for these devices can cause a leakage of current resulting in appropriate device behaviour or premature battery depletion. one or two of these capacitors are used in each device depending on device design. guidant has identified the actual failure mechanism and corrective action has now been implemented. based on experience of reported incidents, capacitor failure is likely to occur in the early part of the device's life period; however it is not possible to estimate when capacitor failure will occur. analysis is ongoing to improve understanding of the prevalence and the time to failure of these devices. to date guidant has confirmed 5 reports of device malfunction associated with this issue out of approximately 27,200 implanted devices worldwide. one device malfunction was discovered at the time of implant; in the other four reports the devices required replacement. to date, approximately 1,500 potentially affected devices have been distributed in the uk and the republic of ireland. guidant believe that the majority of these have already been implanted. approximately 49,800 affected devices have been distributed worldwide. guidant issued a letter with patient management recommendations to clinicians in the uk on 28/06/06 (see appendix 1 in pdf).

See actions on Page 3. Do not implant affected devices. (See list of affected serial numbers distributed in the UK and the Republic of Ireland on our website) Immediately quarantine all affected devices and return them to Guidant in accordance with their instructions. Identify patients implanted with affected devices and review them as soon as possible, giving priority to those who are device dependent or who have not been followed up within the last three months. During follow-up, verify device function using normal programmer follow-up procedures, checking for: no telemetry/pacing output ERI or EOL indications suspected premature battery depletion For specific model families, possible device malfunction behaviours may include (but are not limited to): Incomplete or missing PRM daily measurements Gas gauge not indicating BOL when checked at six month follow-up where the device is not programmed to high output settings Fault code 11 upon interrogation Gas gauge not indicating BOL when checked at six month follow-up where the device is not programmed to high output settings Battery voltage less than 3.10 V within six months of implant Abnormal P&R wave measurements Abnormal signals and markers on real-time or stored electrogram, which may result in inappropriate sensing and therapy *Not distributed within Europe Consult Guidant if you identify any of the above. Consider the risks and benefits of elective device replacement in device dependant patients if any of the above is confirmed. Schedule future patient follow-ups at intervals of no longer than three months for early detection of device failure. Instruct patient to contact their follow-up centre immediately or go to a hospital Accident and Emergency department if they experience a slow heart rate, syncope/light-headedness, inappropriate therapy or new or increased symptoms of heart failure. Report all instances of device failure to MHRA and Guidant. Report explants to the National Pacing and ICD Database (see Contacts on page 4).