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

Model Number PM3242

Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383); Pacemaker Found in Back-Up Mode (1440)

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

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During an in clinic follow-up, the device was found to be in backup vvi (bvv) mode.Upon investigation, the device was found to have reached the elective replacement indicator (eri).Premature battery depletion was suspected, and previous battery longevity estimations were believed to have been overestimated.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

Device was received at eri.Analysis of rco records indicates that rate responsive pacing feature was enabled, and atrial pacing demand increased from feb, 2020 to sep, 2020.When automatic settings are programmed, such as rate responsive pacing feature, the device would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of device.Analysis of device was performed, did not find any anomalies.Longevity assessment was performed and device¿s implanted duration exceeded projected longevity and is considered normal battery depletion.Customer complaint of premature battery depletion, pacemaker found in back-up mode and incorrect measurement was not confirmed.

• 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: 10779364
• MDR Text Key: 214370406
• Report Number: 2017865-2020-16937
• 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
• Report Date: 02/05/2021

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: 06/30/2015
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4381391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention