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

Model Number	5386
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine device exchange, the set screw of the right atrial (ra) port in the header of the device was unable to loosen.The ra lead was cut, and the device was successfully explanted and replaced to resolve this event.The patient was stable.
Additional Manufacturer Narrative
The reported event of could not untighten a-setscrew to remove the lead was confirmed.Analysis revealed that calcified blood was filling the inset of the setscrew.The calcified blood was preventing the wrench from engaging the setscrew inset needed to untighten the setscrew.Wrenches cannot penetrate the calcified blood.The wrench will only strip portions of the inset it comes in contact with.The calcified blood was removed from the setscrew insets in the lab.Then a wrench could be inserted to engage the setscrew to untighten it.The stuck lead could then be removed from the a-connector.The blood came through holes punched through the septum by the user of 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20858952
• Report Number: 2017865-2024-71534
• Device Sequence Number: 8627666
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: (01)05414734006903(10)3486571(17)130331
• 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 Implanted Year: 2011
• Device Explanted Year: 2024
• 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): 06/06/2025

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: 03/31/2013
• Device Model Number: 5386
• Device Lot Number: 3486571
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 02/06/2025; 06/05/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/07/2025; 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2011
• 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