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

Model Number	1948/52
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of an event observed during analysis.
Additional Manufacturer Narrative
No complaint was received with the return of the device.Failure event observed during analysis.Only the connector portion of the lead was returned in one piece.Visual inspection found two external abrasions breaching the outer insulation distal to the connector boot consistent with friction to device can.The outer coil was found to be exposed at both locations.Electrical testing did not find any indication of conductor fractures or internal shorts.

• 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: 25438050
• Report Number: 2017865-2026-11163
• Device Sequence Number: 18731773
• Product Code: NVY
• UDI-Device Identifier: 05414734502344
• UDI-Public: (01)05414734502344(10)P000006399(17)180331
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P960030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: Other
• Device Expiration Date: 03/31/2018
• Device Model Number: 1948/52
• Device Lot Number: P000006399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2015
• 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