BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1861167 · Received October 4, 2010

    Report

    Report Number
    3004209178-2010-07580
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    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
    CA, 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 PAIN IN HIS SHOULDER. THE PT STATED THAT "HE HAD THIS PAIN BEFORE WHEN THE LEAD BROKE." THE PT STATED HIS DOCTOR CHECKED THE DEVICE'S IMPEDANCES AND "EVERYTHING SEEMS TO BE FINE." THE PT ALSO REPORTED THAT HE "GOT A SHOCK FROM USING A MAGNET." ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO 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 61 YR IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL002313P| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU128225V| EXPLANTED:| LEAD: MODEL 3387, LOT# L77388| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-25, LOT# NAF013822N| IMPLANTED:| LOT# NFW134828H| EXPLANTED:| LEAD: MODEL 3387, LOT# L70268