MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) DURATA STS OPTIM ACTIVE FIXATION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	7121/65
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital for right ventricular (rv) lead explant.Device interrogation revealed that the rv lead exhibited varying capture threshold, high pacing impedance, and oversensing noise.Fluoroscopy was performed, and no defects were observed.During the procedure, insulation damage was noted on the right atrial (ra) lead.Both leads were explanted and replaced with new ones.The patient was stable before, during, and after the procedure.
Additional Manufacturer Narrative
Only the distal portion of the lead was returned for analysis.The reported event of high impedance was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.The reported events of inadequate capture and noise were confirmed.Further analysis was performed, and visual analysis noted two internal insulation abrasions under the superior vena cava shock coil breaching the ring electrode and the superior vena cava cable lumen with one of the ring electrode cables abraded and, in both locations, the inner cable lumen intact.The cause of the reported events was isolated to the exposure of the coil on the ring electrode cable.Visual examination also found an external insulation abrasion breaching the sheath only with intact silicone insulation beneath consistent with friction to another device or patient anatomy located at the distal region of the lead.All other damages noted are consistent with procedural damage.

• 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: 24849153
• Report Number: 2017865-2026-07357
• Device Sequence Number: 9047350
• Product Code: LWS
• UDI-Device Identifier: 05414734502122
• UDI-Public: (01)05414734502122(10)2142861(17)110131
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 05/19/2026

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: 01/31/2011
• Device Model Number: 7121/65
• Device Lot Number: 0002142861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2008
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNIFY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male