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

Model Number	1948/52
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a follow-up in clinic.Interrogation revealed that the right ventricular (rv) lead exhibited noise over-sensing which resulted in pacing inhibition.Noise reversion occurred due to the noise over-sensing.The sensitivity of the rv lead was increased to address the issue and will continue to be monitored.No patient symptoms or consequences were 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: 24933723
• Report Number: 2017865-2026-08165
• Device Sequence Number: 18804620
• Product Code: NVY
• UDI-Device Identifier: 05414734502344
• UDI-Public: (01)05414734502344(10)A000100197(17)230731
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P960030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1948/52
• Device Lot Number: A000100197
• 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: 04/10/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2020
• 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 MRI.; TENDRIL STS.
• Patient Age: 77 YR
• Patient Sex: Female