MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP RF CRT-P; NO MATCH

Model Number PM3262

Device Problem Failure to Disconnect (2541)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that during a device replacement procedure due to normal battery depletion, the set screws of the device was unable to be loosened resulting in the inability to disconnect the right atrial (ra) and right ventricular (rv) leads.The ra and rv leads were capped and replaced.The device was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of the atrial and ventricular setscrews could not be untightened to release their leads was confirmed.Analysis revealed both atrial and ventricular setscrews were difficult to untighten due to an accumulation blood in the setscrew insets and in the setscrew/connector block areas.The user was also making incorrect wrench insertions most likely trying to find ways to untighten the setscrews.The blood was most likely not cleaned from the proximal ends of the leads before they were inserted into the connectors at time of implant by the physicians.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17646957
• MDR Text Key: 322240992
• Report Number: 2017865-2023-40616
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/01/2023

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: 11/30/2017
• Device Model Number: PM3262
• Device Lot Number: P000029354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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