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

Model Number	1948/58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a scheduled clinic visit due to heart failure.Interrogation revealed that reduced pacing function and low-voltage measurements on the right ventricular (rv) lead associated with cardiomyopathy.An echocardiogram confirmed reduced low voltage function.The rv lead was capped and replaced on (b)(6)2026.The patient condition 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: 50748137
• Report Number: 2017865-2026-19388
• Device Sequence Number: 8542110
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: (01)05414734502351(10)4789904(17)170930
• 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: 2014
• 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,Followup
• Report Date (Section B): 09/15/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 1948/58
• Device Lot Number: 4789904
• Was Device Available for Evaluation?: No
• 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: 08/25/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2014
• 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: Accent
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown