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Model Number PM2162 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2023 |
Event Type
Injury
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Event Description
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It was reported that the device was explanted and replaced as it is subject to the assurity and endurity pacemaker equipment anomaly advisory issued by abbott on (b)(6) 2023, which applies to a subset of devices distributed and implanted outside of the united states.No malfunction was reported, and the patient is in stable condition with no adverse consequences.
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Manufacturer Narrative
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The reported event was the prophylactic explant of a device that was subject to the assurity and endurity pacemaker equipment anomaly advisory issued by abbott on 10 oct 2023, which applies to a subset of devices distributed and implanted outside of the united states.The device was returned due to advisory with no allegation of a malfunction.Visual inspection of the device and header attachment area did not find any anomalies.Interrogation of the device indicated battery voltage and current within normal range when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).
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Search Alerts/Recalls
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