BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2191106 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-05897
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 5, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS IN THE WRONG LOCATION. ALSO IT WAS REPORTED THAT AN OVERSTIMULATION SENSATION OCCURRED. IT WAS REPORTED THAT WHEN THE PT TURNED UP THE INS UP TO RELIEVE PAIN IN HIS LEFT LEG HE NOW FELT STIMULATION IN RIGHT HIP AND RIBCAGE. THE PT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT HAD AN APPOINTMENT ON (B)(6) 2011. IT WAS REPORTED THAT AN EXPLANT REVISION AND REPLACEMENT TOOK PLACE (B)(6) 2011. A LEAD MIGRATION OCCURRED DUE TO A MOTOR VEHICLE ACCIDENT. THE SYMPTOMS ASSOCIATED WITH THE REPORTED EVENT WERE NO STIMULATION IN THE PAINFUL AREA. THE PT REQUIRED HOSPITALIZATION AFTER THE SURGERY AND RECOVERED WITHOUT SEQUELAE.

    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 46 YR Required Intervention ACCESSORY: MODEL 37752, LOT# NKA150764N| IMPLANTED:| LEAD: MODEL 3777, LOT# V640412017| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE165769N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V663093021| EXPLANTED:| IMPLANTED: