BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 1010586 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01227
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 31, 2007
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS FOUND AN INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL. ONE OF THE RV COILS WAS FRACTURED. THIS DAMAGE MOST LIKELY CAUSED THE RV CABLE AND SVC SHOCK COIL TO SHORT CIRCUIT WHICH CAUSED THE RV CABLE TO BE FRACTURED WHEN IT WAS EXPOSED TO SHOCK. EXTERNAL INSULATION ABRASION WAS FOUND AT 35.5 TO 36.8CM FROM THE CONNECTOR PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *