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

Model Number	1999/52
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's right atrial (ra) lead exhibited noise.No interventions or changes were reported.The patient's condition was unknown.

• 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: 24554940
• Report Number: 2017865-2026-04925
• Device Sequence Number: 9331103
• Product Code: NVN
• UDI-Device Identifier: 05414734502481
• UDI-Public: (01)05414734502481(10)3836227(17)151031
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P960013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: 10/31/2015
• Device Model Number: 1999/52
• Device Lot Number: 3836227
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2012
• 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; QUADRA ASSURA MP; QUARTET
• Patient Age: 68 YR
• Patient Sex: Male