MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISENSE LEAD; NO MATCH

Model Number	1999/46
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient¿s right atrial lead exhibited noise.No changes or interventions were reported.The patient condition was not known.
Additional Manufacturer Narrative
Further information was requested but not received.
Additional Manufacturer Narrative
Correction: section d10 - the correct therapy dates should have been "(b)(6) 2025" rather than "(b)(6) 2025".
Event or Problem Description
New information received noted that the patient presented remotely via merlin.Net.Review of transmission noted that the right atrial (ra) noise exhibited oversensing noise resulted in inappropriate mode switch.Programming changes on the sensitivity were made in clinic.The patient was in stable condition.

• Brand Name: OPTISENSE LEAD
• Common Device Name: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23653611
• Report Number: 2017865-2025-1006044
• Device Sequence Number: 11968250
• Product Code: NVN
• UDI-Device Identifier: 05414734502474
• UDI-Public: (01)05414734502474(10)4341380(17)161130
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 11/30/2016
• Device Model Number: 1999/46
• Device Lot Number: 4341380
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2013
• 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 SVC LEAD; DURATA SVC LEAD; GALLANT DR ICD; GALLANT DR ICD
• Patient Age: 67 YR
• Patient Sex: Male