BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2062819 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02132
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATOR TURNED OFF AFTER THE PATIENT WENT TO (B)(6) TWICE. THE PATIENT PROGRAMMER CONFIRMED THE DEVICE WAS "OFF," AND THE PATIENT WAS ABLE TO TURN THE DEVICE BACK ON WITH THE PATIENT PROGRAMMER. THE PATIENT WAS IN A "(B)(6)" BEFORE GOING TO (B)(6). THE PATIENT HAS 2 STIMULATORS AND IT IS UNCLEAR WHICH STIMULATOR TURNED OFF, SO A REPORT HAS BEEN FILED ON BOTH. SEE MFR REPORT #3004209178-2011-02130 FOR THE OTHER REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7726 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR EXTENSION: MODEL 7482A51, LOT# NHU211462V| PROGRAMMER: MODEL 7438, LOT# NHL027616P| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# NHU211462V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V435220| IMPLANTED:| LOT# NFW161426H| IMPLANTBLE NEURO STIMULATOR, MODEL 7426,| EXTENSION: MODEL 7482A51, LOT# NHU211461V