BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1223304 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03683
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    July 26, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SYNCOPE. ABORTED THERAPY AND A PACING ANOMALY WERE OBSERVED. DUE TO PATIENT WEIGHT LOSS, THE LEAD PULLS WHEN THE PATIENT STANDS UP. LEAD DAMAGE IS SUSPECTED. IT IS UNKNOWN WHEN A REVISION WILL BE DONE. THE LEAD REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1