BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT ADVANCED COMBO MONOCHROME

    MDR report key: 1180911 · Received September 29, 2008

    Report

    Report Number
    1022819-2008-00225
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    May 9, 2007
    Report Date
    May 9, 2007
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Removal / Correction Number
    1022819-11/15/2007-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR EXPORT ONLY.

    Description of Event or Problem · 1

    STIMULATOR OUTPUT SURGED WHILE OUTPUT SETTING WAS AT .1MA. THIS MALFUNCTION CAUSES THE PRINTED CIRCUIT BOARD TO CHANGE THE STIMULATORY PATIENT OUTPUT FROM THE INTENDED OUTPUT TO AN UNINTENDED HIGHER VOLTAGE OUTPUT. WHEN SUCH A MALFUNCTION OCCURS, IT RESULTS IN A SHOCK SENSATION AND POSSIBLE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT ADVANCED COMBO MONOCHROME IPF, IMG, GZJ, HCC, GZI IPF CHATTANOOGA GROUP 2772MC

    Patients

    Seq Age Sex Outcome Treatment
    1