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

Model Number PM3242

Device Problem Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

During device replacement for normal battery depletion, it was reported that the right atrial (ra) lead could not be unscrewed from the header of the device.The ra lead was damaged during attempted removal from the device header, so the ra lead was explanted and replaced in order to resolve the event.The patient was stable following the procedure and there were no adverse consequences.

Manufacturer Narrative

The reported event of unable to untighten the atrial setscrew to remove the lead from the header was confirmed.Analysis revealed the user was making incorrect wrench insertions by not fully inserting the wrench tip into the setscrew inset.This caused the user to strip the setscrew inset.When the inset is being stripped the wrench cannot engage the setscrew to untighten it.Testing revealed that the setscrew could be untightened with full wrench insertion into the inset and with normal force to loosen the setscrew to remove the lead.This problem was caused by the user¿s incorrect use of the torque wrench.

• 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
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12714460
• MDR Text Key: 278876986
• Report Number: 2017865-2021-35408
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: A000066801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1