MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ISOFLEX OPTIM LEAD; Permanent defibrillator electrodes

Model Number	1944/46
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Product Quality Problem (1506); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the right atrial (ra) lead could not be implanted, potentially due to the distal screw at the lead tip and an issue with the lead design.The ra lead was not used and replaced during the procedure.There were no patient consequences.

• Brand Name: ISOFLEX OPTIM LEAD
• Common Device Name: Permanent defibrillator electrodes
• 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: 24750983
• Report Number: 2017865-2026-06660
• Device Sequence Number: 13296826
• Product Code: NVY
• UDI-Device Identifier: 05414734502313
• UDI-Public: (01)05414734502313(10)P000200228(17)270430
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P960030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: Health Professional
• Device Model Number: 1944/46
• Device Lot Number: P000200228
• Was Device Available for Evaluation?: No
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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