MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISENSE LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	1999/40
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the patient presented remotely via merlin.Net.Transmissions showed that the right atrial lead exhibited a low pacing impedance.No intervention was performed.There were no patient's consequences reported.
Event or Problem Description
New information notes noise, low pacing impedance and insulation damage was observed on the atrial lead.The atrial lead was capped 08 feb, 2023 and replaced.The patient was stable.

• Brand Name: OPTISENSE LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• 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: 16281925
• Report Number: 2017865-2023-04808
• Device Sequence Number: 17363673
• 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: 2012
• 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): 02/23/2023

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: 02/28/2015
• Device Model Number: 1999/40
• Device Catalogue Number: 1999-40
• Device Lot Number: 3642832
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2012
• 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: LEFT VENTRICLE LEAD; QUADRA ALLURE MP PACER; TENDRIL LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male