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

Model Number	1999/40
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient right atrial (ra) lead exhibited noise oversensing that caused pacing inhibition and inappropriate mode switch.No programming changes were made.No patient consequences reported.
Event or Problem Description
New information received noted that the right atrial (ra) lead was capped and replaced on (b)(6) 2023.The patient was stable throughout the procedure.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17358557
• Report Number: 2017865-2023-36290
• Device Sequence Number: 20464080
• Product Code: NVN
• UDI-Device Identifier: 05414734502467
• UDI-Public: 05414734502467
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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: 03/31/2015
• Device Model Number: 1999/40
• Device Catalogue Number: 1999-40
• Device Lot Number: 3684745
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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: ACCENT DR; TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female