BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2130253 · Received June 13, 2011

    Report

    Report Number
    3004209178-2011-04335
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    December 1, 2010
    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
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF STIMULATION SENSATION. THE RIGHT LEAD HAD BROKEN. IMPEDANCES WERE MEASURED AND ALL WERE "OVER." THE PT COULD NOT FEEL ANY STIMULATION FROM THE RIGHT LEAD EVEN WHEN THE NEUROSTIMULATOR AMPLITUDE WAS TURNED UP TO 10.5V. THE RIGHT LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2011. THE PT WAS DOING FINE AND GETTING GOOD STIMULATION COVERAGE. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 PROGRAMMER: MODEL 37743, LOT# NKE101580N| LEAD: MODEL 377745, LOT# V009873| IMPLANTED:| EXPLANTED:| LEAD: MODEL 377745, LOT# V017721| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA110389N