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

Model Number	7121/60
Medical Device Problem Codes	Break (1069); High impedance (1291); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pacing lead impedance on the right ventricular (rv) lead had slowly increased since (b)(6) 2021 and was now above the normal range.An insulation breach was suspected though no sign of lead damage was noticeable on chest x-ray.The rv lead was capped (b)(6) 2022 and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported events of ¿suspected insulation breach¿, high pacing lead impedance and high pacing threshold were not confirmed.A partial lead (connector portion) was returned in one piece.Lead impedance test could not be performed due to as received procedural damage to the lead.During electrical testing the lead failed hi-pot test due to procedural damage at the connector region.X-ray examination did not find any indication of conductor fractures.Visual inspection of the lead did not find any anomalies with the exception of procedural damage.
Event or Problem Description
New information received notes inadequate capture was als observed on the right ventricular lead prior to the procedure to cap the lead on (b)(6) 2022.The capped lead was removed during an unrelated procedure and returned.The patient was stable.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15260245
• Report Number: 2017865-2022-19839
• Device Sequence Number: 5811322
• Product Code: LWS
• UDI-Device Identifier: 05414734502115
• UDI-Public: 05414734502115
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 01/16/2023

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: 07/31/2011
• Device Model Number: 7121/60
• Device Catalogue Number: 7121-60
• Device Lot Number: 2693449
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2008
• 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: 79 YR
• Patient Sex: Female