BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1980283 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-00799
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 18, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A FADING SENSATION WHERE THE STIMULATION NEEDED TO BE CONTINUALLY INCREASED. THE PT BARELY FELT THE STIMULATION EVEN AT 9.0 VOLTS. IT WAS DETERMINED THAT THE PATIENT'S DEVICE HAD MULTIPLE OVERDISCHARGES. THEIR NEUROSTIMULATOR WAS REPLACED. F/U VISIT SHOWED THAT HE WAS GETTING GREAT PAIN RELIEF AND HAD NO OTHER COMPONENTS.

    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 EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE130359N| ACCESSORY: MODEL 37752, LOT# NKA124381N| LEAD: MODEL 39286-65, LOT# N210704003| IMPLANTED: