BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2892121 · Received January 2, 2013

    Report

    Report Number
    3007566237-2013-00001
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNCONSCIOUS AND THE PATIENT'S MOTHER TRIED TO TELL THE EMERGENCY MEDICAL SERVICES (EMS) THAT THE PATIENT HAD A "STOMACH PACEMAKER." THE REPORTER STATED THAT THE EMS HAD "NO CLUE ABOUT IT." IT WAS UNCLEAR WHEN THE EVENT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925 UNKNOWN IMPLANTABLE NEUROSTIMULATOR INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other