BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2905513 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13583
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AT THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEFIBRILLATION THRESHOLDS WERE PERFORMED WITH A THRESHOLD OF 0.09V, AMPLITUDES OF 12MV AND IMPEDANCES OF 1300 OHMS. HOWEVER, THE THRESHOLDS INCREASED TO 2.2V, AMPLITUDES DROPPED TO 7MV AND THE PACING IMPEDANCES DECREASED TO 720 OHMS. THE PATIENT WAS SCHEDULED FOR FURTHER DEFIBRILLATION THRESHOLD TESTING. THIS PATIENT WAS NOT DEVICE DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIELD REPRESENTATIVE LATER REPORTED THAT DEFIBRILLATION THRESHOLD TESTING WAS SUCCESSFUL. THE THRESHOLD INCREASED TO 2.4V WITH OTHER LEAD MEASUREMENTS STABLE AND THE PATIENT WILL BE EVALUATED IN THE NEAR FUTURE AT THEIR SIX WEEK POST IMPLANT FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10778 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R 0295| E142| 4470