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

Model Number	7171Q/65
Medical Device Problem Codes	Over-Sensing (1438); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the lead was explanted due to a potential product performance issue.No further information was provided.
Additional Manufacturer Narrative
Correction to add related report number.
Event or Problem Description
New information was received that the right ventricular lead exhibited oversensing of noise.The patient was stable following explant.
Additional Manufacturer Narrative
The reported event of noise was not confirmed.As received, a partial lead was returned in two pieces.Electrical testing did not find any indication of conductor fractures or internal shorts.X-ray examination of the partial lead did not find any anomalies except for procedural damage.An additional finding was discovered unrelated to the reported event.Visual inspection of the partial lead found external insulation abrasion breaching the optim sheath with intact silicone insulation beneath at the proximal region.The cause of external insulation abrasion is consistent with friction to the device can.
Additional Manufacturer Narrative
Correction: updating patient weight.

• Brand Name: DURATA STS OPTIM PASSIVE 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: 23770770
• Report Number: 2017865-2025-1007033
• Device Sequence Number: 18577681
• Product Code: NVY
• UDI-Device Identifier: 05414734503297
• UDI-Public: (01)05414734503297(10)S000026680(17)171130
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup,Followup
• Report Date (Section B): 01/26/2026

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 Expiration Date: 11/30/2017
• Device Model Number: 7171Q/65
• Device Lot Number: S000026680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 12/10/2025; 01/14/2026; 01/26/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/16/2025; 12/19/2025; 01/16/2026; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2016
• 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: Male
• Patient Weight: 73 KG