BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2030438 · Received March 9, 2011

    Report

    Report Number
    3004209178-2011-01782
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    April 1, 2010
    Report Date
    February 23, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT EXPERIENCED A SHOCKING SENSATION WHILE BEING REPROGRAMMED. PT STATED THIS EVENT HAPPENED SOON AFTER IMPLANT AND NOW SHE IS AFRAID TO USE OTHER PROGRAMS. SHE NEEDS TO FEEL STIMULATION IN HER FEET DUE TO HER NEUROPATHY AND CURRENTLY ISN'T GETTING COVERAGE. MFR'S REP WILL SEE THE PT AT HER NEXT OFFICE VISIT FOR REPROGRAMMING. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 252640002| IMPLANTED:| LEAD: MODEL 3777, LOT# V503646025| PROGRAMMER: MODEL 37743, LOT# NKE151543N| IMPLANTED:| LEAD: MODEL 3777, LOT# V503675001