MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 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	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer report number: 2017865-2023-48457 it was reported that the patient presented to the hospital for a scheduled generator change out procedure.During the procedure, it was found that the right atrial (ra) lead had failed to be disconnected from the header of the pacemaker.The pacemaker was explanted and replaced, while the ra lead was capped during the same procedure on (b)(6) 2023.The patient had no adverse consequences.
Additional Manufacturer Narrative
The reported event of could not untighten the atrial setscrew to remove the lead was confirmed.Analysis revealed that calcified blood was filling the a-setscrew inset.The calcified blood was preventing the wrench from entering and 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.When the calcified blood was removed in the lab, a wrench could be fully inserted into the setscrew inset and the setscrew could be untightened normally, and the stuck lead removed.The blood came through holes punched through the septum by the torque wrench at time of implant.Device has normal battery depletion to end of life (eol).

• Brand Name: IDENTITY ADX XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17935109
• Report Number: 2017865-2023-48455
• Device Sequence Number: 12375794
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2024

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: 02/28/2007
• Device Model Number: 5386
• Device Lot Number: 0002307031
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/12/2023; 04/19/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 01/01/2024; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2005
• 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