MAUDE Adverse Event Report: ABBOTT ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5157M/S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During explant due to normal battery depletion, it was reported that the torque wrench could not remove from the set screw from the header of the device.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
The reported event of setscrew could not be untightened was confirmed.Analysis revealed a wrench tip was broken off inside the inset of the setscrew.Now the setscrew cannot be untightened because the broken wrench tip is blocking other wrenches from inserting into the setscrew inset.The wrench tip fractured from over-torquing and over-tightening of the setscrew far beyond what the wrench was designed to handle at the time of the initial device implant.The user was not using a torque wrench which should have been used.Torque wrenches are required to be used but was not used by the person connecting the lead to the device.

• Brand Name: ADX XL DR
• 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: 17114068
• Report Number: 2017865-2023-22962
• Device Sequence Number: 15106315
• Product Code: DXY
• UDI-Device Identifier: 05414734006774
• UDI-Public: 05414734006774
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 07/13/2023

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: 11/30/2012
• Device Model Number: 5157M/S
• Device Catalogue Number: 5157M/S
• Device Lot Number: 3410641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2011
• 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