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

Model Number	1948/58
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with syncope.It was noted that the right ventricular (rv) lead and right atrial (ra) lead were found to be broken.Both the rv and ra leads were explanted, and a dual-chamber leadless pacemaker was implanted on (b)(6)2026.Patient status was not reported.

• 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: 50205216
• Report Number: 2017865-2026-16792
• Device Sequence Number: 5545447
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: (01)05414734502351(10)A000019381(17)190228
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 02/28/2019
• Device Model Number: 1948/58
• Device Lot Number: A000019381
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2016
• 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: Assurity Pacemaker.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 121 LB