BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2050150 · Received April 1, 2011

    Report

    Report Number
    3004209178-2011-02474
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    November 1, 2010
    Report Date
    March 15, 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
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED, THE PT REC'D PAIN RELIEF WHEN STANDING OR WALKING BUT NO RELIEF WHEN SITTING. IT WAS STATED, THE PT'S DEVICE HAD NOT WORKED AS WELL AFTER IMPLANT, BUT THE PT HAD ALSO BEEN HURT WHEN WALKING IN TO A GLASS DOOR. IT WAS ALSO STATED THAT "IF SHE (PT) IS ON HER FEET A LOT, SHE GETS RED ITCHY SPOTS ON HER ANKLES AND THEY SWELL." THE PT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 72 YR IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE158325N| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA146970N| LEAD: MODEL 3778, LOT# V574652017| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V574652019| IMPLANTED:| EXPLANTED: