BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2163481 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-08761
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD PRESENTED TO THE HOSPITAL DUE TO VENTRICULAR TACHYCARDIA. IT WAS FOUND THAT THE PATIENT HAD ATTEMPTED TO SELF EXPLANT THEIR DEVICE. THE EMERGENCY ROOM STAFF NOTED THE DEVICE WAS HANGING OUT OF THE POCKET BY THE LEADS. IT WAS REPORTED THE LEAD HAD DISLODGED DUE TO THE ATTEMPTED SELF EXPLANT. THE SYSTEM WAS THEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 4135| 0184| E110