MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) OPTISENSE LEAD; NO MATCH

Model Number	1999/46
Medical Device Problem Codes	Signal Artifact/Noise (1036); Under-Sensing (1661); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented remotely to the clinic via merlin.Net transmission.Review of the transmission indicated that the right atrial (ra) lead demonstrated noise, low pacing impedance, and undersensing, which resulted in inaccurate arrhythmia reporting.The patient was subsequently brought into the clinic, where the physician elected to cap and replace the ra lead on (b)(6) 2026.The patient remained in stable condition.
Additional Manufacturer Narrative
Correction: section d4: primary unique device identification (udi) number should have been (b)(4) rather than (b)(4) as entered in the initial report 2017865-2026-08754 submitted on (b)(6) 2026.Correction: section h1: the type of reportable event should have been "serious injury" rather than "malfunction" as entered in the initial report 2017865-2026-08754 submitted on (b)(6) 2026.

• 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: 25024615
• Report Number: 2017865-2026-08754
• Device Sequence Number: 10185920
• Product Code: NVN
• UDI-Device Identifier: 05414734502474
• UDI-Public: (01)05414734502474(10)3924202(17)160131
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 01/31/2016
• Device Model Number: 1999/46
• Device Lot Number: 3924202
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2013
• 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: DURATA.; QUADRA ASSURA.; QUARTET.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female