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

Model Number	7120/65
Medical Device Problem Codes	Break (1069); High impedance (1291); Over-Sensing (1438); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that sensing noise was noted on the right ventricular (rv) lead.The pacing impedance had decreased, and on the day of the event, the pacing impedance measurement was high, out of range.Insulation damage was suspected.An x-ray and ct scan were performed.The rv lead was explanted and replaced.There were no adverse events to the patient.
Additional Manufacturer Narrative
The reported event of sensing noise, high pacing lead impedance, and insulation damage was confirmed, while the reported event of low pacing lead impedance was not confirmed.As received, a partial lead was returned in two pieces for analysis.Visual and x-ray inspection found the ring electrode cables fractured and separated distal to the suture sleeve tie impressions.The cause of sensing noise and high pacing lead impedance was due to ring electrode cables, consistent with fatigue fracture.An external insulation abrasion breaching the ring electrode cable lumen was found proximal to the suture sleeve tie impressions.In this location, the inner coil lumen was breached, but the ptfe liner of the inner coil and ring electrode etfe cables coating were intact.An external insulation abrasion breaching the optim sheath was also found proximal to the suture sleeve tie impressions.Lead insulation was intact at that location.The cause of insulation damage is consistent with friction to device can.Electrical testing did not find any indication of internal shorts.All other damage found is 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: 24861519
• Report Number: 2017865-2026-07634
• Device Sequence Number: 10476507
• Product Code: LWS
• UDI-Device Identifier: 05414734502092
• UDI-Public: (01)05414734502092(10)
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 09/30/2011
• Device Model Number: 7120/65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female