MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number	7121Q/52
Medical Device Problem Codes	Over-Sensing (1438); Low impedance (2285); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the right ventricular lead exhibited low pacing impedance and r-wave amplitude variation.No changes or intervention was performed; the patient would continue to be monitored.The patient condition was stable.
Event or Problem Description
New information indicates that a lead revision was attempted, but was unsuccessful due to patient anatomy.The patient condition was stable before, during, and afterwards.
Additional Manufacturer Narrative
The reported events of low pacing lead impedance, noise and r wave amp variation were confirmed.As received, a complete lead was returned in two pieces.During electrical testing the lead failed hi-pot test.Destructive analysis was performed and visual inspection found internal insulation abrasion breaching all the cable lumens along with the inner coil lumen under the right ventricular shock coil.The etfe cable coating of both right ventricular cables and the ptfe liner of the inner coil were abraded in this location.The cause of the reported events was isolated to the internal insulation abrasion abrading the ptfe liner of the inner coil and the etfe cable coating of both right ventricular cables.
Event or Problem Description
New information indicates that the lead was explanted and replaced.The patient condition was stable before, during, and after.
Event or Problem Description
New information indicates that the lead was explanted and replaced.The patient condition was stable before, during, and after.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• 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: 12129836
• Report Number: 2017865-2021-25140
• Device Sequence Number: 19824920
• Product Code: NVY
• UDI-Device Identifier: 05414734503211
• UDI-Public: 05414734503211
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/24/2023

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: 02/28/2017
• Device Model Number: 7121Q/52
• Device Catalogue Number: 7121Q-52
• Device Lot Number: 4488539
• 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: 06/30/2021
• Supplement Date Received by Manufacturer: 02/24/2023; 05/25/2023; 06/07/2023; 07/14/2023
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 03/20/2023; 05/31/2023; 06/08/2023; 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2014
• 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: Male