BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173359 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11078
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT 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 DEVICE SYSTEM DETECTED A SHOCK IMPEDANCE LESS THAN 20 OHMS. IT WAS REPORTED THAT THE PREVIOUS SEVEN DAILY MEASUREMENTS WERE IN THE 50'S OHMS RANGE. THE PATIENT WAS BROUGHT IN TO THE CLINIC FOR A FOLLOW UP APPOINTMENT THE FOLLOWING DAY. UPON DEVICE INTERROGATION, IMPEDANCE MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. THE PATIENT'S PHYSICIAN PLANNED TO CONTINUE MONITORING THE DEVICE SYSTEM REMOTELY. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 0185| 4088| 0175| E102| T175