MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number	7171Q/65
Medical Device Problem Codes	Failure to Capture (1081); 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
During the preparation for a routine device replacement procedure, a loss of capture and r wave amplitude variation was noted on the right ventricular (rv) lead.During the device replacement procedure, the rv lead was capped and replaced to resolve the event.The patient was stable.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16629487
• Report Number: 2017865-2023-15989
• Device Sequence Number: 14783355
• Product Code: NVY
• UDI-Device Identifier: 05414734503297
• UDI-Public: 05414734503297
• Combination Product (Y/N): Y
• Initial Reporter Country: PO
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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: 04/30/2014
• Device Model Number: 7171Q/65
• Device Catalogue Number: 7171Q-65
• Device Lot Number: 3737362
• Was Device Available for Evaluation?: No
• 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: 03/13/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2012
• 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