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

Model Number	5386
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the device exchange, the set screw was stripped and was unable to be removed from the header.The event was resolved by applying more force with the screwdriver to remove the set screw.The patient experienced no adverse consequences.
Additional Manufacturer Narrative
The reported event of difficulty removing the atrial lead was confirmed.Analysis revealed that calcified blood was filling the atrial 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 will just strip the portions of the inset it comes in contact with.This is what was occurring in the operating room during the explant.After the setscrew inset was stripped a tool was then used (by the consultant) that engaged the stripped inset and it untightened the setscrew and the lead could then be removed.The blood came through holes punched through the septum by the torque wrench at time of implant.

• 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: 15222561
• Report Number: 2017865-2022-17433
• Device Sequence Number: 6672979
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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
• Report Date (Section B): 10/17/2022

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: 12/31/2009
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 2904574
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 08/13/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2008
• 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: RIGHT ATRIAL LEAD
• Patient Sex: Unknown