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

Model Number	7170Q/65
Medical Device Problem Codes	Low impedance (2285); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the clinic after receiving a shock.Device interrogation revealed that the implantable cardioverter-defibrillator (icd) misinterpreted the atrial fibrillation with rapid ventricular rate as ventricular tachycardia and delivered an inappropriate shock.It was also found via interrogation that the right ventricular (rv) lead exhibited low defibrillation impedance and an over current detection (ocd) alert.Programming changes were made, and the patient¿s condition remained stable.
Event or Problem Description
New information received indicates that the right ventricular (rv) lead and the implantable cardioverter-defibrillator (icd) were explanted and replaced with new ones.There were no complications during the surgery.
Additional Manufacturer Narrative
The reported event of low defib impedance was not confirmed.Only the distal portion of the lead was returned for analysis.Electrical testing that could be measured did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies with the exception of procedural damage.

• 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: 24597528
• Report Number: 2017865-2026-05255
• Device Sequence Number: 9417307
• Product Code: NVY
• UDI-Device Identifier: 05414734503266
• UDI-Public: (01)05414734503266(10)S000033655(17)180531
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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: 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): 05/21/2026

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: 05/31/2018
• Device Model Number: 7170Q/65
• Device Lot Number: S000033655
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 05/21/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/01/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male