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

Model Number	7120Q/52
Medical Device Problem Codes	Failure to Capture (1081); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a lead revision procedure to correct the lead dislodgement due to twiddler and the lead exhibit failure to capture and improper sensing.Besides, it was noted that the device had migrated and exhibited failure to capture and improper sensing.The infection was noted once the pocket was open.The entire gallant system including the right atrial lead and the right ventricular lead were explanted due to pocket infection, there was no allegation of infection being device or procedure related.The patient was in stable condition throughout the procedure.
Additional Manufacturer Narrative
Correction: b6: previously need to mention fluoroscopy in the b6 - relevant tests/laboratory data, including dates section.
Additional Manufacturer Narrative
The reported events were dislodgment, failure to capture, sensing issue, and twiddlers.As received, a complete lead was returned for analysis.X-ray examination of the lead found the inner coil was over torqued at the connector region, and the helix extended and covered with blood / tissue.After cutting, cleaning and applying torque directly to the inner coil, the helix could be retracted and extended.The full helix extension length was measured within specification.The reported events of failure to capture and a sensing issue were note confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.All damages found are consistent with procedural damage.

• Brand Name: DURATA STS OPTIM ACTIVE 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20243974
• Report Number: 2017865-2024-65131
• Device Sequence Number: 12614142
• Product Code: NVY
• UDI-Device Identifier: 05414734503037
• UDI-Public: (01)05414734503037(10)A000137631(17)260131
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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: 01/31/2026
• Device Model Number: 7120Q/52
• Device Lot Number: A000137631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 08/30/2024; 11/13/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 09/18/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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 Age: 70 YR
• Patient Sex: Female