BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1935937 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10178
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFORMATION REPORTING THE PT WAS NOT ABLE TO ADJUST STIMULATION ON THE RIGHT SIDE, HER LEFT WAS WORKING FINE. STATES THAT AT 2:00 P.M. TODAY SHE FELT A RETURN OF HER SYMPTOMS. SYMPTOMS INCLUDED NOT BEING ABLE TO STAND UP, FEELING WEAK IN HER LEGS, SPEECH IS BAD AND SHE CAN FEEL HER LEG SHAKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF REC'D A F/U REPORT WILL BE SENT. REFERENCED MFR REPORT #3004209178201010179.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR IMPLANTED:| LOT# NFW141257H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXTENSION: MODEL 7482A, LOT# NHU147309V| LEAD: MODEL 3389S-40, LOT# V010293| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V017959| LEAD: MODEL 3389S-40, LOT# V010293| EXTENSION: MODEL 7482A, LOT# NHU147311V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: