BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1860535 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15153
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE RV DEFIBRILLATION LEAD WAS DISPOSED AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM AN OUT-OF-SERVICE (OOS) FORM THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD DISLODGED. THE PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND THE RV DEFIBRILLATION LEAD WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R E102| 0158| 0157