BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 1841864 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-07152
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD VOMITING AND NAUSEA. PT WAS UNSURE WHETHER HER STIMULATION WAS TURNED ON. THE PT WAS IMPLANTED IN (B)(6) BUT WAS CURRENTLY TRAVELING IN FLORIDA. THE PT SAW A PHYSICIAN IN FLORIDA AND WAS INFORMED THE FOLLOWING: THE PT HAD A HERNIA, THE IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED INCORRECTLY AND THE PARAMETERS WERE SET AT 6.0V. THE PT SUBSEQUENTLY REPORTED SHE RECENTLY LOST 50 POUNDS AND THE IMPLANT HAS MOVED. THE PHYSICIAN RECOMMENDED A REVISION TO REPOSITION THE DEVICE AND BELIEVED THE PT'S WEIGHT LOSS MAY HAVE LOOSENED IN THE POCKET. THERE WAS NO KNOWN INCIDENT RELATED TO THIS COMPLAINT. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MDT PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR IMPLANTED:| LEAD: MODEL 4351, LOT# NHT008889N| LEAD: MODEL 4351, LOT# NHT008898N| IMPLANTED:| EXPLANTED:| EXPLANTED: