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

Model Number	7121Q/52
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that high capture threshold was observed on the right ventricular (rv) lead.No intervention was performed.The patient was stable.
Event or Problem Description
New information received indicated that the right ventricular (rv) lead was extracted and replaced due to elevated capture thresholds.That patient was asymptomatic before, during, and after the procedure.
Additional Manufacturer Narrative
The reported event of high capture threshold was not confirmed by analysis.During analysis, a failure event was observed, which was unrelated to the reported event.Final analysis found two external insulation abrasions breaching the optim sheath with intact silicone insulation beneath at the proximal and distal region.The cause of external insulation abrasions is consistent with friction to device can and friction to another device or feature of patient anatomy.

• 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: 17209159
• Report Number: 2017865-2023-24343
• Device Sequence Number: 14812768
• Product Code: NVY
• UDI-Device Identifier: 05414734503211
• UDI-Public: 05414734503211
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 09/05/2023

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: 11/30/2012
• Device Model Number: 7121Q/52
• Device Catalogue Number: 7121Q-52
• Device Lot Number: 3549973
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 09/01/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/27/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2011
• 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: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; RIGHT ATRIAL LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female