MAUDE Adverse Event Report: ABBOTT ISOFLEX OPTIM LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	1948/58
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The estimated implant date is in 2022.
Event or Problem Description
During a remote follow-up, noise that resulted in over-sensing and pacing inhibition was observed on the right ventricular (rv) lead.The patient is pacemaker dependent.No intervention has been performed, although a lead replacement is anticipated.The patient is stable and will continue to be monitored.
Event or Problem Description
Additional information was received that provocative testing was performed and the noise was reproducible.The lead was capped and replaced to resolve the event.

• Brand Name: ISOFLEX OPTIM LEAD
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25669420
• Report Number: 2017865-2026-13333
• Device Sequence Number: 13375062
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: (01)05414734502351(10)P000138055(17)241130
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: P960030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2026

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: 11/30/2024
• Device Model Number: 1948/58
• Device Lot Number: P000138055
• 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: 06/17/2026
• Supplement Date Received by Manufacturer: 07/03/2026; 07/14/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 07/13/2026; 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2021
• 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