MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) OPTISENSE LEAD; No Match

Model Number	1999/46
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	Valvular Insufficiency/ Regurgitation (4449)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular lead displayed high pacing impedance and lead integrity issue was suspected.Mild valvular regurgitation was noted.The atrial lead showed oversensing due to noise.Both leads were capped on (b)(6) and successfully replaced.The patient was stable.

• Brand Name: OPTISENSE LEAD
• Common Device Name: No Match
• 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: 25208905
• Report Number: 2017865-2026-10362
• Device Sequence Number: 8963721
• Product Code: NVN
• UDI-Device Identifier: 05414734502474
• UDI-Public: (01)05414734502474(10)3514258(17)140930
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/18/2026

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: 09/30/2014
• Device Model Number: 1999/46
• Device Lot Number: 3514258
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female