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

Model Number	5386
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During device explant due to normal battery depletion, it was reported there was difficulty disconnecting the right ventricular lead and right atrial leads from the device header, leading to a prolonged procedure time.A different hex wrench was used to successfully disconnect the leads and to resolve the event.The patient was stable following the procedure and there were no adverse consequences.
Additional Manufacturer Narrative
The reported event of difficulty untightening both setscrews to remove the leads was confirmed.Analysis revealed that calcified blood was filling the ventricular setscrew inset.The calcified blood was preventing the wrench from engaging the setscrew inset to untighten the setscrew.Wrenches cannot penetrate the calcified blood.The wrench stripped the portions of the inset it came in contact with.The use of other tools managed to engage enough of the stripped inset to untighten the setscrew.The blood came through holes punched through the septum by the torque wrench at time of implant.Analysis of the atrial setscrew found the user of the wrench was had difficulty aligning the wrench so that it would drop into the setscrew inset to engage and untighten the setscrew.This setscrew was normal with no calcified blood filling it.

• Brand Name: IDENTITY 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15503627
• Report Number: 2017865-2022-39738
• Device Sequence Number: 8132847
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 12/08/2022
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2009
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 2957757
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 11/22/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/18/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2007
• 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