MAUDE Adverse Event Report: ABBOTT OPTISENSE LEAD; No Match

Model Number	1999/52
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069); Low impedance (2285)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a follow-up in-clinic, episodes of noise and decreased pacing impedance resulting in arrhythmia were observed on the right atrial (ra) lead.Ra lead damage was alleged, but not confirmed.Reprogramming was performed to resolve event.The patient was stable and will continue to be monitored.

• Brand Name: OPTISENSE LEAD
• Common Device Name: No Match
• 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: 24707549
• Report Number: 2017865-2026-05535
• Device Sequence Number: 10467246
• Product Code: NVN
• UDI-Device Identifier: 05414734502481
• UDI-Public: (01)05414734502481(10)3521051(17)141031
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 10/31/2014
• Device Model Number: 1999/52
• Device Lot Number: 3521051
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2011
• 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: FORTIFY ASSURA DR ICD, US
• Patient Sex: Unknown