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

Model Number	7170Q/65
Medical Device Problem Codes	Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient's right ventricular (rv) lead presented with r-wave amplitude variation and high capture thresholds due to micro dislodgement.The rv lead was explanted and replaced in a procedure on (b)(6) 2023.Post-procedure there were no patient consequences.
Additional Manufacturer Narrative
Further information requested but not received.
Additional Manufacturer Narrative
The reported events were lead dislodgement, r-wave amplitude variation and inadequate capture.As received, a complete lead was returned in one-piece.Visual examination found two tines to be cut off and were not returned, consistent with procedural damage.There was no sign that the tines were missing due to incomplete molding.The reported events of r-wave amplitude variation and inadequate capture were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual and x-ray examination did not find any other anomalies.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18352158
• Report Number: 2017865-2023-95007
• Device Sequence Number: 20938831
• Product Code: NVY
• UDI-Device Identifier: 05414734503266
• UDI-Public: 05414734503266
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 02/09/2024

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: 02/28/2023
• Device Model Number: 7170Q/65
• Device Lot Number: A000120991
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 01/22/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/05/2024; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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: ATRIAL LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 111 KG