BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911420 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15959
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 THIS DEVICE SYSTEM DETECTED INCREASED SHOCK IMPEDANCE MEASUREMENTS, ULTIMATELY REACHING GREATER THAN 125 OHMS ON DAILY MEASUREMENTS. THE PATIENT WITH THIS SYSTEM WAS BROUGHT INTO THE CLINIC FOR FURTHER DEVICE TESTING. A COMMANDED MEASUREMENT ALSO DECLARED THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. ALL OTHER LEAD MEASUREMENTS WERE STABLE AND WITHIN ACCEPTABLE LIMITS. THE DEVICE WAS ULTIMATELY REPROGRAMMED TO A DIFFERENT CONFIGURATION THROUGH THE PROXIMAL COIL WITH ACCEPTABLE IMPEDANCE MEASUREMENTS. THE PATIENT WAS TO BE SEEN AGAIN IN THREE MONTHS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18622 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R E110| 0185| T165| 4470