BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2113822 · Received May 17, 2011

    Report

    Report Number
    3007566237-2011-03575
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 TROUBLE RECHARGING HIS STIMULATOR. THE PT FELL DOWN THE STAIRS MONTHS BACK AND ONCE A MONTH WHEN HE TRIES TO RECHARGE LYING DOWN AND IS ABLE TO RECHARGE STANDING UP. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# N0037389| LEAD: MODEL 3778, LOT# N0037389| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD013407N