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

Model Number PM3562

Device Problem Misconnection (1399)

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

Event Date 10/14/2020

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 the implant procedure, the set screw could not be secured in the device header.A new device was used to complete the procedure, and the patient was stable with no consequences.

Manufacturer Narrative

The reported event of difficulty tightening and untightening the setscrew was confirmed.Analysis found that the user made incorrect wrench insertions into the left ventricular (lv) setscrew.The wrench was being forced down into the setscrew inset without it being aligned to go into the setscrew inset.The corners of the wrench tip were being wedged into the setscrew inset walls.This damaged the inset walls and also the wrench cannot engage the inset walls to tighten the setscrew like this.The wrench will only strip the inset which is observed as part of the damage to the setscrew inset.The damage to the setscrew inset made the setscrew difficult to tighten and to untighten.The problem is related to the user¿s use of the torque wrench.Electrical testing was performed, and the device had normal characteristics throughout all test phases with no anomalies noted.

• 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: 10750454
• MDR Text Key: 213630561
• Report Number: 2017865-2020-16320
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: P000102658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1