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

Model Number PM3242

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the device reached elective replacement indicator (eri) sooner than expected.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Customer complaint of premature discharge of battery was not confirmed.The pacer was received in normal working conditions with battery voltage at eri.Electrical and mechanical analysis performed, indicated normal device functionality.The implant duration exceeds the projected longevity based on average monthly current indicating normal battery depletion.

• Brand Name: ALLURE QUADRA RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11174802
• MDR Text Key: 226997675
• Report Number: 2017865-2021-00901
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• 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,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4917606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/20/2021; 03/25/2021
• Supplement Dates FDA Received: 01/28/2021; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention