BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2081430 · Received April 22, 2011

    Report

    Report Number
    3004209178-2011-03025
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH BALANCE ISSUES AND BEING DIZZY FOLLOWING EXPOSURE TO A THEFT DETECTOR OR SECURITY GATE AT WALMART. SINCE TURNING THERAPY BACK ON THE PT WAS DOING WELL. ADDITIONAL INFORMATION WAS REQUESTED.

    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 78 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU198991V| LEAD: MODEL 3389S-40, LOT# V250050