MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number	PM3542
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During device replacement for normal battery depletion, damage was observed on the device header of the right atrial port.A different device was successfully implanted to resolve the event.The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
The reported event of the atrial set screw coming out of the device stuck to the wrench tip was confirmed.Analysis revealed the atrial set screw became stuck to the tip of the torque wrench and was pulled out of the device through the septum stuck to the wrench tip.This happened when the user made incorrect wrench insertions into the set screw.The wrench tip was not being aligned to go into the hex shaped inset.The physician forced the wrench tip down into the set screw inset with the corners of the wrench tip going down and becoming wedged into the set screw inset walls.This stuck the wrench in the set screw inset.When the user pulled the wrench out of the device, the set screw stuck to the tip was pulled out of the device with it.This problem is related to the user¿s incorrect use of the torque wrench.The set screw anomaly was consistent with having occurred during the procedure.

• Brand Name: QUADRA ALLURE MP
• Common Device Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 21860722
• Report Number: 2017865-2025-40450
• Device Sequence Number: 4719545
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: (01)05414734510080(10)P000193585(17)250831
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/30/2025

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: 08/31/2025
• Device Model Number: PM3542
• Device Lot Number: P000193585
• Was Device Available for Evaluation?: No
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 06/28/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown