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	High impedance (1291); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow-up in clinic.It was noted that the right ventricular (rv) lead exhibited high pacing impedance and high capture thresholds, while the right atrial (ra) lead was over-sensing noise which was suspected to be caused by an insulation break.The patient was asymptomatic.The rv and ra leads were explanted and replaced successfully.The patient was stable throughout the procedure.
Additional Manufacturer Narrative
The reported events of high pacing impedance and unacceptable threshold were not confirmed.As received, a partial lead was returned in two pieces.Electrical testing was normal.Lead impedance testing could not be performed due to the condition of the partial lead as received.Visual and x-ray examinations of the partial lead did not find any anomalies except for procedural damage.During analysis, a failure event was observed which was unrelated to the reported event.Visual inspection of the partial lead found two external insulation abrasions breaching the optim sheath with the silicone insulation beneath intact at the proximal region.The cause of external insulation abrasions is consistent with friction to device can.
Additional Manufacturer Narrative
D9 should be (b)(6) 2026 in follow up 1.

• 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: 24366547
• Report Number: 2017865-2026-03232
• Device Sequence Number: 20140727
• Product Code: NVY
• UDI-Device Identifier: 05414734503297
• UDI-Public: (01)05414734503297(10)S000028960(17)180131
• 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: 2018
• Device Explanted Year: 2026
• 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): 04/20/2026

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: 01/31/2018
• Device Model Number: 7171Q/65
• Device Lot Number: S000028960
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/19/2026; 04/14/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/07/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2017
• 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: FORTIFYASSURA DR ICD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG