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

Model Number	7170/65
Medical Device Problem Codes	Capturing Problem (2891); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an implant procedure that the right ventricular (rv) lead had unacceptable capture threshold; multiple positions were attempted.The rv lead was not used and the physician elected to complete the procedure with a different rv lead.There were no patient consequences.
Additional Manufacturer Narrative
Correction: b5 - corrected the description for unacceptable r-waves that were noted.Correction: h6 - corrected coding to include device sensing problem.
Event or Problem Description
It was reported that during an implant procedure that the right ventricular (rv) lead had unacceptable sensing of r-waves; multiple positions were attempted.The rv lead was not used and the physician elected to complete the procedure with a different rv lead.There were no patient consequences.
Additional Manufacturer Narrative
The reported event of sensing r-wave amplitude variation was confirmed.Electrical testing did not find any indication of conductor fractures.Shorting was noted between the inner coil to ring electrode conductor path.X-ray examination found bunching of the inner coil noted at the connector region consistent with damage occurring at the time of the procedure.The reported event was isolated to the damaged inner coil at the connector region.

• Brand Name: DURATA STS OPTIM PASSIVE 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16618703
• Report Number: 2017865-2023-15800
• Device Sequence Number: 20332622
• Product Code: LWS
• UDI-Device Identifier: 05414734502436
• UDI-Public: 05414734502436
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 7170/65
• Device Catalogue Number: 7170-65
• Device Lot Number: A000095893
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 03/30/2023; 05/23/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/12/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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
• Patient Sex: Unknown