BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040920 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01100
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. 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 THIS RECENTLY IMPLANTED RIGHT VENTRICULAR DEFIBRILLATION LEAD HAD DISLODGED POST POCKET CLOSURE, HOWEVER REFIXATED ITSELF TO THE PATIENT'S CAPILLARY. THE LEAD WAS TESTED AND THRESHOLD MEASUREMENTS WERE APPROPRIATE SO THE PHYSICIAN ELECTED TO NOT INTERVENE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PATIENT IS NOT PACER DEPENDENT.

    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 58 YR 0184| E102