BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2690205 · Received August 10, 2012

    Report

    Report Number
    3007566237-2012-01928
    Event Type
    Injury
    Date Received
    August 10, 2012
    Report Date
    July 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V221331, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V126057, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A REPLACEMENT THE NEW INS TOOK 24 HOURS TO REDUCE THE PATIENT'S SHAKING, AND THE PATIENT WAS STILL NOT FEELING QUITE RIGHT FOUR DAYS AFTER IMPLANT. THE PATIENT DIDN'T THINK HER VOICE WAS SOUNDING RIGHT. THE PATIENT FELL THE DAY PRIOR TO REPORT, AND THE PATIENT THINKS IT WAS THE BATTERY THAT MADE HER FALL. THE PATIENT SPRAINED HER ANKLE. THE PATIENT WASN'T SURE HOW SHE FELL. IT WAS STATED THAT EVERYONE WAS TELLING THE PATIENT THAT IT WAS HER BATTERY THAT MADE HER FALL. 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
    1 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other