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

Model Number	5156
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a scheduled procedure.During the procedure, the physician found it impossible to remove the leads from the device because of a defect in the screw it was not gripping.After multiple attempts the lead was removed and replaced.There were no patient consequences.
Additional Manufacturer Narrative
The reported event of cannot untighten the setscrew to remove the lead was confirmed.Analysis revealed that calcified blood was filling the setscrew inset, preventing the wrench from engaging it.Wrenches cannot penetrate calcified blood so the wrench can only be partially inserted into the setscrew inset.Since the wrench cannot engage the inset, it will slip around in the inset and strip that portion of the inset it is in contact with without untightening the setscrew.The physician took the necessary action which was to dig out the calcified blood blocking wrench insertion into the setscrew inset.The wrench could then insert far enough in and engage the unstripped portion of the inset to untighten the setscrew normally.This problem most often occurs when blood passes through a hole punched in the septum by the user of the torque wrench at the time of implant.

• Brand Name: VERITY ADX SR
• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23992580
• Report Number: 2017865-2026-00478
• Device Sequence Number: 21388021
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: (01)05414734006767(10)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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 Model Number: 5156
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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