BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION LEAD

    MDR report key: 1050835 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01781
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 15, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THE SHOCK IMPEDANCE HAD DECREASED OVER TIME. AN INSULATION ANOMALY WAS SUSPECTED. HOWEVER, FLUOROSCOPY REVEALED THAT THE SVC COIL HAD DISLODGED AND IN CONTACT WITH THE RV COIL. ATTEMPTS WERE MADE TO PULL BACK THE SVC COIL, BUT IT WAS UNSUCCESSFUL. THE DECISION WAS MADE TO TURN OFF THE SVC COIL AND LEAVE THE DEFIB PORTION ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention