BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1944606 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19775
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 8, 2010
    Report Date
    November 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    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 CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD CUT THE DEVICE OUT OF THEIR CHEST. THIS LEAD WAS PARTIALLY SEVERED. RV PACE IMPEDANCE WAS >2000 OHMS. NOISE WAS NOT PRESENT AND THE PATIENT HAD NOT RECEIVED ANY INAPPROPRIATE THERAPY. THE DEVICE WAS PLACED BACK IN THE POCKET. IT HAD NOT BEEN DETERMINED YET WHETHER OR NOT TO REPLACE OR REMOVE THE SYSTEM. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SYSTEM WAS EXPLANTED AT A LATER DATE DUE TO A PATIENT INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R 4046| 4469| N119| 0175