BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2041418 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02273
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO THE PT WAS NOT ABLE TO ADJUST STIMULATION. PT PROGRAMMER DISPLAYED SHOWED "CALL YOUR DOCTOR" ICON. POWER ON RESET CONDITION. MFR'S REP ATTEMPTED TO CLEAR THE POR ON THE PHONE WITH THE PT BUT WAS NOT SUCCESSFUL. SHE WILL MEET WITH THE PT IN PERSON AND CLEAR THE POR. PT ALSO COMPLAINED OF BROKEN RECHARGER BELT WHICH WAS REPLACED BY THE REPAIR DEPARTMENT. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D A F/U REPORT WILL BE SENT.

    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 71 YR PROGRAMMER: MODEL 37743, LOT# NKE115915N| EXTENSION: MODEL 37081, LOT# NJB045706V| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB045707V| LEAD: MODEL 39565-30, LOT# N171369004| IMPLANTED:| EXPLANTED:| IMPLANTED: