BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1941211 · Received December 22, 2010

    Report

    Report Number
    3004209178-2010-10682
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 9, 2010
    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

    THE STIMULATION TURNED OFF ONCE; IT MAY HAVE HAPPENED WHILE AT A STORE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. SEE ALSO MFR'S REPORT #3004209178-2010-10681.

    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 64 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU113184V| LOT# NFW158449H| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU113185V| EXPLANTED:| LEAD: MODEL 3387S, LOT# V218104| IMPLANTED:| LEAD: MODEL 3387S, LOT# V224586