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

Model Number	5156
Medical Device Problem Codes	Break (1069); Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: 2017865-2025-10816.It was reported that patient presented for a follow up in clinic.It was noted that the right atrial lead exhibited high pacing impedance.During the lead replacement procedure, it was noted that the header failed to lock the lead on the port hence unable to reconnect the lead.The lead was capped and replaced on (b)(6) 2024.The pacemaker was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported event of could not tighten the setscrew to fix the lead was not confirmed.Analysis found the device normal.The setscrew was found normal with the hex inset undamaged with no stripping.Nothing was preventing torque wrench insertion into the setscrew inset.Lab testing found is-1 lead could be fully inserted into the connector port and the setscrew could be fully tightened down on the lead normally.The lead was held firmly in the connector.No device anomalies were found.A user related issue may have occurred with tightening the setscrew on the lead.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21154825
• Report Number: 2017865-2025-10815
• Device Sequence Number: 9190185
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: (01)05414734006767(10)4699209(17)160131
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• 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): 03/14/2025

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: 01/31/2016
• Device Model Number: 5156
• Device Lot Number: 4699209
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2014
• 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