BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPL LEAD

    MDR report key: 1050840 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01786
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 28, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW HV LEAD IMPEDANCE WAS OBSERVED DURING INDUCTION TESTING. THE PATIENT WAS RESCUED BY AN EXTERNAL DEFIBRILLATOR AFTER TWO HIGH VOLTAGE THERAPIES DID NOT DEFIBRILLATE THE INDUCED VF. A FLUOROSCOPY REVEALED DEGREDATION OF THE LEAD AT THE DISTAL PART OF THE RV COIL. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPL LEAD DEFIBRILLATION LEAD DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION SP02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention