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

Model Number	1999/46
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow up in clinic.It was noted that the right atrial lead exhibited under-sensing and could not pick up any p waves.The lead was capped and replaced on (b)(6) 2026.The patient was in a stable condition.

• 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: 25120534
• Report Number: 2017865-2026-09580
• Device Sequence Number: 8661177
• Product Code: NVN
• UDI-Device Identifier: 05414734502474
• UDI-Public: (01)05414734502474(10)3259696(17)131130
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: 11/30/2013
• Device Model Number: 1999/46
• Device Lot Number: 3259696
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/08/2026
• 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: DURATAARECIBO LEAD; QUICKFLEX MICRO LEAD; UNIFY ASSURA ICD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male