BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2163063 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07370
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 27, 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.

    Additional Manufacturer Narrative · 1

    TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO THE PRODUCTS ERODING THROUGH THE PATIENT'S SKIN. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED INDICATED A NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS UNSUCCESSFUL DUE TO THE PATIENT'S HIGH DFTS. A LIFE VEST PLANNED TO BE PLACED ON THE PATIENT FOR ONE MONTH UNTIL ANOTHER SYSTEM COULD BE IMPLANTED ON THE LEFT SIDE.

    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 79 YR Life Threatening| R 4470| A135| 0158| T165