BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1823585 · Received August 27, 2010

    Report

    Report Number
    3004209178-2010-06532
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    April 16, 2008
    Report Date
    July 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH OF THE PT'S NEUROSTIMULATORS WERE FLIPPED. IT WAS NOTED THAT SHE HAD LARGE BREASTS WHICH POSSIBLY CONTRIBUTED TO THE FLIPPING. ADDITIONAL INFORMATION WAS REQUESTED. SEE MANUFACTURER REPORT #3004209178-2010-06535.

    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 55 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENTION: MODEL 7482A51, LOT# NHU164241V| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V006360