MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3562

Device Problems Premature Discharge of Battery (1057); No Pacing (3268)

Patient Problem Fatigue (1849)

Event Date 07/04/2021

Event Type  Injury  

Event Description

The patient reported feelings of fatigue.Subsequently the non-pacemaker dependent patient was hospitalized due to atrioventricular block and the pacemaker was not pacing.The physician alleged premature battery depletion.The event was resolved by explanting and replacing the pacemaker.The patient was in stable condition.

Manufacturer Narrative

The reported events of premature battery depletion and no output were confirmed.The device was received with no telemetry communication and no output due to battery at end of life (eol) level.The device was cut open to enable further testing and the battery was found depleted.Analysis performed after replacing external power supply found high current drain.Hybrid leakage test did not find any anomaly.Capacitor leakage test was performed, and high current was noted on a capacitor which showed the most likely cause of high current to be a capacitor anomaly.Assessment of total projected longevity was performed, and premature battery depletion was observed.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12149428
• MDR Text Key: 260955266
• Report Number: 2017865-2021-25478
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000106507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention