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

Model Number	PM3242
Medical Device Problem Codes	Over-Sensing (1438); Failure to Disconnect (2541); No Pacing (3268)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a device replacement procedure due to normal elective replacement indicator (eri), the set screw of the device was difficult to be loosened.Noise resulting in oversensing and pacing inhibition was noted on the right ventricle channel while actively loosening the setscrew, resulting in the patient experiencing asystole.Loosening of the setscrew was halted, device pacing continued, and the asystole was terminated.The physician considered the asystole episodes to be short and not clinically significant.Loosening of the setscrew was completed and the device was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of difficulty untightening the setscrew was confirmed.Analysis revealed that the user/physician stripped the setscrew inset.The abbott torque wrenches cannot be examined since they were discarded.No device anomalies were found.The problem is related to the user¿s use of the torque wrenches.

• Brand Name: ALLURE QUADRA RF CRT-P
• Common Device Name: 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 22285985
• Report Number: 2017865-2025-87612
• Device Sequence Number: 8373738
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: (01)05414734507912(10)4841847(17)160430
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: PM3242
• Device Lot Number: 4841847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 09/06/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL STS.
• Patient Sex: Unknown