BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1872213 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07965
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PT STATED STIMULATION TURNED OFF YESTERDAY. THE PT WAS HOME AND STATUS WAS UNK. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    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 59 YR LEAD: MODEL LEADMVD, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL026726P| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU203456V