BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913672 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00469
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 27, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    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 DISPLAYED A LOW SHOCK IMPEDANCE MEASUREMENT. THEN FOLLOWING DAY, THE PATIENT WITH THIS DEVICE SYSTEM WAS PRESENTED IN THE CLINIC FOR FURTHER DEVICE REVIEW. ALL CURRENT LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. IT WAS NOT BELIEVED THE PATIENT TO BE INVOLVED WITH ANY ELECTROMAGNETIC INTERFERENCE (EMI). ISOMETRIC AND ARM MOVEMENT EXERCISES WERE PERFORMED, HOWEVER, NONE RECREATED THE OUT OF RANGE MEASUREMENT. LEAD IMPEDANCE TESTING AND TWO COMMANDED SHOCK TESTS WERE PERFORMED, RESULTING IN WITHIN ACCEPTABLE LIMITS MEASUREMENTS. THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE DEVICE SYSTEM. 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
    20817 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening E141| T135| 0157