BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2524665 · Received April 4, 2012

    Report

    Report Number
    MW5024940
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    March 28, 2012
    Report Date
    April 4, 2012
    Manufacturer
    ST JUDE MEDICAL, CARDIAC RHYTHM MGMT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANTED SYSTEM: ICD IS A MEDTRONIC SECURA DR D224DRG ICD, SN: (B)(4), IMPLANTED ON (B)(6) 2011. ATRIAL LEAD IS A ST JUDE MEDICAL 1488TC, SN: (B)(4), IMPLANTED ON (B)(6) 2002. RV/DEFIBRILLATOR LEAD IS A ST JUDE MEDICAL RIATA 1581-65, SN: (B)(4), IMPLANTED ON (B)(6) 2002. LOW IMPEDANCE < 20 OHMS ON THE HV LEAD. ICD: WHEN THE DEVICE TRIED TO DELIVER ENERGY, IT COULD ONLY DELIVER 0.2 TO 0.3 JOULES DUE TO EXCEPTIONALLY LOW IMPEDANCE, LESS THAN 20 OHMS. THIS IS A RIATA LEAD WHICH IS ON ADVISORY. FAILURE OF SYSTEM DID NOT RESULT IN HARM TO THE PT DUE TO PRESENCE OF LVAD, AND THE TYPE OF ARRHYTHMIA THE PT HAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL RIATA ICD LEAD LWS ST JUDE MEDICAL, CARDIAC RHYTHM MGMT 1581-65

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| S