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); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for generator explant procedure.During the procedure, it was noted that the set screw of the pacemaker was stripped which resulted in the right ventricular lead failed to be removed from the pacemaker header.It was also noted that the set screw and the lead were damaged.The pacemaker was explanted and the lead was capped on (b)(6) 2025.The patient was recovering and stable post procedure.
Additional Manufacturer Narrative
The reported event of could not remove the lead from the header was confirmed.Analysis revealed there was blood accumulation in the connector port zones.The blood in these areas had a bonding effect between the inside areas of the connector port and the surfaces of the lead body.This prevented removal of the lead.Blood was most likely not cleaned from the proximal end of the lead before insertion into the connector by the physician at 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: 22050274
• Report Number: 2017865-2025-64108
• Device Sequence Number: 9280267
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: (01)05414734006767(10)2124588(17)090531
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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: 05/31/2009
• Device Model Number: 5156
• Device Lot Number: 0002124588
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 08/16/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 05/23/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2007
• 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
• Patient Age: 87 YR
• Patient Sex: Female