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

Model Number PM3262

Device Problem Failure to Disconnect (2541)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

During a routine device replacement procedure, it was noted there was difficulty removing the right ventricular (rv) lead from the header of the device.Silicone oil was applied and the rv lead was able to be removed from the device header.The device was replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported event of difficulty removing the right ventricular (rv) lead from the header could not be confirmed.The lead had been removed.Testing found the dimensions of the connector ports were normal.The lead removal force was normal.Nothing was found in the connector port to cause the lead removal problem.No device anomalies were found.The problem could not be duplicated.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12366637
• MDR Text Key: 268103872
• Report Number: 2017865-2021-29011
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• 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: 10/25/2021

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: 09/30/2017
• Device Model Number: PM3262
• Device Catalogue Number: PM3262
• Device Lot Number: P000025950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 10/24/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1