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

Model Number PM3562

Device Problem Failure to Interrogate (1332)

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

Event Date 06/25/2020

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 attempted to be interrogated via radio frequency (rf) but was unsuccessful.It was then determined that the cause of the event was due to an rf lockout.The device was explanted and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

The reported event of radio frequency (rf) lockout and failure to interrogate was not confirmed.Data analysis of the device image suggested rf telemetry lockout had occurred in the field due to excessive rf usage in a short period of time.This lockout feature disables the high-power telemetry to prevent battery drain due to unintended excessive usage.As received, the lockout period had expired.Device showed normal characteristics and able to be interrogated successfully on various merlin programmers.Rf telemetry could be enabled and disabled with no issue.The device was received in normal range of operation.The device was then programmed to nominal settings for the remainder of the analysis.The results of all electrical test performed, including thermal and mechanical stress testing indicate no anomalies.Longevity assessment was performed, and device is considered normal battery depletion.

• 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: 10252610
• MDR Text Key: 198170934
• Report Number: 2017865-2020-08694
• 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: 09/15/2020

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: 04/30/2020
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000069785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention