BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2130310 · Received June 13, 2011

    Report

    Report Number
    3004209178-2011-04365
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HAVING COMMUNICATION ISSUES BETWEEN THE RECHARGER AND THE NEUROSTIMULATOR. HE SPENT HALF AN HOUR MOVING THE RECHARGER AROUND BUT ONLY COULD GET 2 BARS. HE EVEN SLEPT ON THE RECHARGER FOR 2 NIGHTS BUT THIS FAILED TO CHARGE THE DEVICE. IT WAS THEN CONFIRMED THAT THE NEUROSTIMULATOR WAS FLIPPED IN THE POCKET. IT WAS THEN PROPERLY PLACED AND SUTURED IN THE POCKET WITH THE RESULT THAT THE PT WAS ABLE TO COMMUNICATE AGAIN WITH THE DEVICE. HE WAS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention ACCESSORY: MODEL 37752, LOT# NKA151533N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE165759N| LEAD: MODEL 39565-65, LOT# V661726003