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

Model Number	1948/52
Medical Device Problem Codes	Under-Sensing (1661); Low impedance (2285); Capturing Problem (2891); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented remotely via remote monitoring transmission.Review of the transmission noted right ventricular (rv) lead exhibited high capture threshold, low impedance, and under-sensing, which consistent to rv lead dislodgement.The rv lead dislodgement was confirmed via live fluoroscopy.Programming changes were made to address the rv lead under-sensing.Subsequently, the rv lead was capped and replaced on (b)(6) 2026.The patient remained in stable condition.

• 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: 50726835
• Report Number: 2017865-2026-18960
• Device Sequence Number: 10575052
• Product Code: NVY
• UDI-Device Identifier: 05414734502344
• UDI-Public: (01)05414734502344(10)P000224872(17)280131
• 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: 2026
• 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): 09/11/2026

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 Model Number: 1948/52
• Device Lot Number: P000224872
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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 Pacemaker.; UltiPace Lead.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male