BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2042405 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01606
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD HAD EXHIBITED SHOCK IMPEDANCES LESS THAN 20 OHMS ALL THE TIME WITH THE NON-INVASIVE SHOCK IMPEDANCE MEASUREMENT. TWO SYNCHRONOUS 5J SHOCKS WERE DELIVERED TO THE MEASURING OF THE IMPEDANCE. THE FIRST TEST WAS DELIVERED IN A DUAL-COIL CONFIGURATION. SHOCK IMPEDANCE 35 OHMS. THE SECOND TEST WAS EXPLAINED IN A SINGLE-COIL CONFIGURATION. SHOCK IMPEDANCE 44 OHMS. THE SHOCK IMPEDANCE REMAINED IN A NORMAL RANGE AND THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0155

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R F161| 0145| 0155| 1793| MISMATCH