MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; Implantable cardioverter defibrillator (non-CRT)

Model Number	7120/60
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No complaint was received with the return of the device.A failure event was observed during analysis.As received, a partial lead (only connector portion) was returned in one piece.Visual examination found two external insulation abrasions breaching the optim sheath with intact silicone insulation beneath, and the right ventricular cable lumen with the right ventricular ethylene tetrafluoroethylene (etfe) cable coating was also noted abraded proximal to the suture tie impression.The inner coil lumen and polytetrafluoroethylene (ptfe) liner were intact.The cause of external insulation abrasions is consistent with friction to device can.
Event or Problem Description
This report is to advise of an event occurring during analysis.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Common Device Name: Implantable cardioverter defibrillator (non-CRT)
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25568472
• Report Number: 2017865-2026-12803
• Device Sequence Number: 5166329
• Product Code: LWS
• UDI-Device Identifier: 05414734502085
• UDI-Public: (01)05414734502085(10)2152980(17)110430
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: Other
• Device Expiration Date: 04/30/2011
• Device Model Number: 7120/60
• Device Lot Number: 0002152980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2008
• 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