MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) OPTISURE ACTIVE FIXATION; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	LDA210/65
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: (b)(4).It was reported, that a patient presented with an impedance issue noted, on the right atrial led over-sensing of noise noted, on the right ventricular lead.Inappropriate shock was delivered, as a result of the over-sensing.Both leads were capped on (b)(6) 2024.The patient was stable throughout.
Event or Problem Description
Related manufacturer reference number: (b)(4).It was reported that a patient presented remotely via merlin.Net.Review of the transmission revealed an impedance issue on the right atrial lead and over-sensing of noise on the right ventricular lead.Inappropriate anti-tachycardia pacing (atp) therapy was delivered as a result of the over-sensing.Both leads were capped and replaced on (b)(6) 2024.The patient was stable throughout.

• Brand Name: OPTISURE ACTIVE FIXATION
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 20703581
• Report Number: 2017865-2024-70016
• Device Sequence Number: 13164409
• Product Code: NVY
• UDI-Device Identifier: 05414734507172
• UDI-Public: (01)05414734507172(10)S000025604(17)190930
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P950022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/19/2024

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: 09/30/2019
• Device Model Number: LDA210/65
• Device Lot Number: S000025604
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2016
• 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: FORTIFY ASSURA
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 86 YR
• Patient Sex: Female