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

Model Number	PM3542
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the initial implant procedure, the set screw was unable to be loosened resulting in difficulty disconnecting the lead from the device.Additional force was applied and the set screw was removed from the header, attached to the hex wrench.The device was not implanted and was replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of difficulty tightening then untightening the rv-setscrew was confirmed.Analysis revealed the user of the torque wrench was incorrectly inserting the wrench causing the wrench to strip the setscrew inset.After the setscrew is stripped it cannot be tightened and there will be difficulty loosening it.The user then forced the wrench into the inset trying to engage the setscrew, but this wedged the corners of the wrench tip in the inset walls sticking the setscrew to the wrench tip.The setscrew stuck to the wrench was then pulled out of the device through the septum.The problem is related to the user¿s incorrect use of the wrench.The setscrew anomaly was consistent with having occurred during the procedure.

• Brand Name: QUADRA ALLURE MP
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: 16446203
• Report Number: 2017865-2023-11001
• Device Sequence Number: 20187806
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: 05414734510080
• 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): 06/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: PM3542
• Device Catalogue Number: PM3542
• Device Lot Number: P000153819
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2022
• 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
• Patient Sex: Unknown