MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) ISOFLEX OPTIM LEAD; Permanent Defibrillator Electrodes

Model Number	1948/58
Medical Device Problem Codes	Capturing Problem (2891); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Dizziness (2194); Syncope/Fainting (4411)
Date of Event	09/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital for a scheduled pacemaker replacement procedure and extraction of the right ventricular (rv) leads.The patient had experienced syncope and dizziness associated with diminishing r-wave amplitudes and elevated capture thresholds related to both the active and previously capped rv leads.Fluoroscopic evaluation confirmed that the active rv lead had become dislodged.During the procedure, the pacemaker and active rv lead were explanted and replaced.The previously capped rv lead was also explanted on (b)(6) 2026.Subsequently, a new leadless pacemaker system was implanted.The patient remained stable throughout the procedure.

• 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: 50914704
• Report Number: 2017865-2026-20503
• Device Sequence Number: 17528966
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: (01)05414734502351(10)P000188415(17)261130
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P960030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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): 09/28/2026

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 Model Number: 1948/58
• Device Lot Number: P000188415
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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 Sex: Unknown