BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6233335

    MDR report key: 6233335 · Received January 9, 2017

    Report

    Report Number
    6233335
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 12, 2016
    Report Date
    December 14, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN ICD EXCHANGE. THE PULSE GENERATOR WAS DETACHED FROM THE ELECTRODES. THE EXPOSED DISTAL ENDS OF THE ELECTRODES WERE CAREFULLY INSPECTED FOR INTEGRITY OF THE INSULATION AND CONDUCTOR COIL. NO ABNORMALITIES WERE NOTED. THE LV LEAD WAS CAPPED AND THE RV AND RA LEADS WERE INSERTED INTO THE NEW PULSE GENERATOR. THE DEVICE WAS INTERROGATED AND THE NEW DUAL CHAMBER ICD GENERATOR WAS NOTED TO BE STUCK IN NOISE REVERSION MODE. ADDITIONAL TESTING AND RE-PROGRAMMING WERE ATTEMPTED. THE DEVICE WAS RECHECKED TO ENSURE ALL CONNECTIONS WERE CORRECT BUT THE DEVICE WAS STUCK IN NOISE REVERSION MODE. THE PRIOR PULSE GENERATOR WAS GIVEN THE REPRESENTATIVE TO BE ANALYZED BY THE COMPANY. THE NEW PULSE GENERATOR WAS ATTACHED AND NO NOISE REVERSION MODE WAS DETECTED. MANUFACTURER RESPONSE FOR ICD, ELLIPSE NEXT GEN DR 36 (PER SITE REPORTER): THE REPRESENTATIVE WAS PRESENT IN THE PROCEDURE ROOM AND RETRIEVED THE DEVICE IMMEDIATELY AFTER IT WAS FOUND TO BE NON-OPERATIONAL.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR THE PATIENT ALSO HAS AN LVAD