BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2040928 · Received March 23, 2011

    Report

    Report Number
    3004209178-2011-02235
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 17, 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 PREVIOUS (B)(6) THE PT FELT SHE SAW A "FIREBALL" COME FROM THE RECHARGER ANTENNA. IT WAS NOTED THAT THE PT IS LEGALLY BLIND. SHE FELT A SHOCKING THROUGH HER ENTIRE BODY. IT WAS OBSERVED THAT SHE HAD A BRUISE EIGHT INCHES SUPERIOR TO THE INS AND 4-5 INCHES LATERAL FROM SPINE. SEVERAL DAYS LATER THE PT WAS IN HER PHYSICIAN'S OFFICE WHERE SHE RECHARGED FOR 1.5 HOURS WITH NO COMPLAINTS OR UNUSUAL EVENTS. THE MFR REP FELT IT WAS POSSIBLE THE SHOCKING SENSATION WAS THE RESULT OF CHANGING POSITION (GOING FROM STANDING TO LYING DOWN). FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    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 73 YR PROGRAMMER: MODEL 37743, LOT# NKE162529N| LEAD: MODEL 39565-65, LOT# V585126009| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA150571N| IMPLANTED: