ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY RF DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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Model Number PM2240 |
Device Problems
Failure to Interrogate (1332); No Pacing (3268)
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Patient Problem
Arrhythmia (1721)
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Event Date 07/24/2023 |
Event Type
Injury
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Event Description
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It was reported, that patient presented in-clinic after experiencing arrhythmia.Upon evaluation, it was noted, that patient's pacemaker was not able to be interrogated.The pacemaker was explanted and replaced.The patient was stable.
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Manufacturer Narrative
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The reported event of failure to interrogate was confirmed.The device was received with no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found at normal level.Hybrid circuitry was tested, indicating high current drain, consistent with moisture damage, depleting the battery prematurely and resulting in the reported events.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.
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Event Description
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It was also noted that patient's pacemaker had no low voltage output.
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Search Alerts/Recalls
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