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

Model Number	7121/75
Medical Device Problem Codes	Fracture (1260); Over-Sensing (1438); Retraction Problem (1536)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient pre-procedure exhibited chronic systolic heart failure.It was noted that noise consistent with a fracture was suspected on the right atrial (ra) and right ventricular (rv) leads.During a procedure to extract the leads, the helices could not be retracted.The ra and rv leads were explanted and replaced.The patient was discharged.
Additional Manufacturer Narrative
Correction: section a4, patient weight.
Additional Manufacturer Narrative
The reported events were lead fracture, oversensing noise and helix mechanism issue.A partial lead was returned in two pieces.The reported event of oversensing noise was confirmed.After removing the ring electrode conductor cables from the ring electrode cables lumen to examine the condition of the cables ethylene tetrafluoroethylene (etfe) coating, the etfe coating on both ring electrode conductor cables was found to be abraded at the distal region of the lead.The cause of the reported event of oversensing noise was isolated to the abraded ring electrode conductor cables etfe coating exposing the ring electrode cables.The reported event of helix mechanism issue was confirmed.Visual examination of the lead found the helix was extended and clogged with blood/tissue.After cutting the lead, cleaning the distal portion of the lead and applying torque directly to the inner coil, the helix was able to retract and extend.The measured helix extension length was within specification.The cause of the reported event of helix mechanism issue was isolated to the helix clogged with blood/tissue.The reported event of lead fracture was not confirmed.X-ray examination and electrical testing of the lead did not find any indication of conductor fractures.
Additional Manufacturer Narrative
Correction: section g3, the date received by manufacturer for the last report submitted for the device evaluation should have been (b)(6) 2026, the analysis completion date, not (b)(6) 2026, the submission date.

• 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: 24880118
• Report Number: 2017865-2026-07778
• Device Sequence Number: 15911425
• Product Code: LWS
• UDI-Device Identifier: 05414734502139
• UDI-Public: (01)05414734502139(10)2773514(17)120331
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/22/2026

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: 03/31/2012
• Device Model Number: 7121/75
• Device Lot Number: 2773514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/13/2026; 04/27/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/13/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2009
• 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: FORTIFY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 176 KG