MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	5386
Medical Device Problem Codes	Failure to Disconnect (2541); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient presented for a routine generator replacement.During the procedure, the right ventricular set screw on the pacemaker could not be loosened due to a header anomaly.The right ventricular lead was capped and the pacemaker was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of could not untighten the ventricle setscrew to remove the lead was confirmed.The pacemaker was returned for analysis.Analysis revealed that calcified blood was filling the v-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.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.

• 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: 17347821
• Report Number: 2017865-2023-36017
• Device Sequence Number: 14963005
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: 01/31/2009
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 0002217103
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2007
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PASSIVE PLUS DX
• Patient Sex: Unknown