MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	LDA210Q/52
Medical Device Problem Codes	Failure to Capture (1081); Low impedance (2285); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the right ventricular (rv) lead exhibited decreased pacing impedance and loss of capture.An x-ray was performed confirming rv lead dislodgement.The physician explanted and replaced the rv lead.The patient condition was stable.
Additional Manufacturer Narrative
The reported events were dislodgement, failure to capture, and low pacing impedance.As received, a complete lead with a stylet and a clip-on-tool was returned in one piece for analysis.The reported events of failure to capture and low pacing impedance were not confirmed.Visual inspection of the lead found helix was retracted and clogged with blood.X-ray examination found no anomalies on the lead.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 23659209
• Report Number: 2017865-2025-1006120
• Device Sequence Number: 18655821
• Product Code: NVY
• UDI-Device Identifier: 05414734507318
• UDI-Public: (01)05414734507318(10)A000175980(17)280630
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LDA210Q/52
• Device Lot Number: A000175980
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/05/2025; 01/29/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/08/2025; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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: GALLANT.; ULTIPACE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown