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	Failure to Deliver Shock/Stimulation (1133); Low impedance (2285); Charging Problem (2892)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	10/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the patient received a shock for a true vt event.However, there was an alert indicating "possible high voltage lead issue.Alternative shock configurations have been attempted".It was noted, that the third attempted shock configuration was successful at converting the arrhythmia.The lead was capped and replaced on (b)(6) 2024.There were no patient consequences.
Additional Manufacturer Narrative
The reported events of low defib impedance and ¿possible high voltage lead issue¿ were confirmed.As received, a partial lead (only connector portion) was returned in one piece.Visual examination noted an external insulation abrasion breaching the right ventricular cable lumen with one of the right ventricular etfe cable coatings found abraded.The cause of the reported events is consistent with friction to device can.

• 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: 20538980
• Report Number: 2017865-2024-68285
• Device Sequence Number: 12843272
• Product Code: NVY
• UDI-Device Identifier: 05414734503297
• UDI-Public: (01)05414734503297(10)3781229(17)130831
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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
• Report Date (Section B): 10/28/2025

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: 08/31/2013
• Device Model Number: 7171Q/65
• Device Lot Number: 3781229
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2012
• 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: ISOFLEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male