MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	7170Q/65
Medical Device Problem Codes	Break (1069); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a remote follow up, noise resulting in oversensing was observed on the right ventricular (rv) lead.It was suspected the lead was damaged.The rv lead was explanted and replaced to resolve the event.T he patient was stable.
Additional Manufacturer Narrative
The reported event of oversensing noise was not confirmed.As received, a complete lead was returned in two pieces.Electrical testing did not find any indication of conductor fractures however an internal short was found between right ventricular and superior vena cava cables due to procedural damage.Additional findings unrelated to the reported event(s): visual inspection of the lead found an external insulation abrasion breaching the optim sheath with intact silicone insulation proximal to suture tie impression.The cause of external insulation abrasion is consistent with friction to device can.

• Brand Name: DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18320534
• Report Number: 2017865-2023-94709
• Device Sequence Number: 15293244
• Product Code: NVY
• UDI-Device Identifier: 05414734503266
• UDI-Public: 05414734503266
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: 04/30/2015
• Device Model Number: 7170Q/65
• Device Lot Number: 3684751
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown