MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM PASSIVE FIXATION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	7170/65
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular lead failed to capture.The lead was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of failure to capture was not confirmed.As received, a complete lead was returned in one piece with all four tines intact and undamaged.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray examinations of the lead did not find any anomalies except for procedural damage.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18887473
• Report Number: 2017865-2024-34613
• Device Sequence Number: 2997844
• Product Code: LWS
• UDI-Device Identifier: 05414734502436
• UDI-Public: 05414734502436
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 07/31/2026
• Device Model Number: 7170/65
• Device Lot Number: A000146212
• 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: 02/18/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2023
• 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 Sex: Unknown