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

Model Number PM3562

Device Problems Failure to Interrogate (1332); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During an implant procedure, the device lost rf telemetry.The device was interrogated using inductive telemetry and it was revealed to be in backup mode.Technical support reviewed the device image and noted a drop in battery voltage.The device was explanted and replaced to resolve the event.The patient was in stable condition following the procedure.

Manufacturer Narrative

Additional information: d10, h3, h6 the customer complaint of backup mode was confirmed.Device was returned in backup mode due to unknown power on reset (por).Analysis of the device image revealed unknown code corruption to be the cause of the por.After reloading the code successfully, functional electrical testing revealed no anomalies, and the battery voltage was still in the normal range of operation.The device was monitored for several days with normal results and the backup condition could not be reproduced despite extensive efforts.As a result of this finding, abbott is performing further investigation.

• 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: 10212183
• MDR Text Key: 196957268
• Report Number: 2017865-2020-08404
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000090478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1