BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2120168 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04021
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 6, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS WALKING INTO THE SCANNING ROOM HAVE AN MRI WHEN SHE WAS "VIOLENTLY SHOCKED AND THROWN BACK." SHE HAD A STROKE AND MULTIPLE SEIZURES WITHIN A WEEK. HER IMPLANTABLE NEUROSTIMULATOR WAS CHECKED AND THE IMPEDANCES WERE TESTED BUT THE RESULTS WERE NOT PROVIDED. HER ATTORNEY ALLEGES THE DEVICE WAS EXPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP 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 47 YR Required Intervention LEAD: MODEL 3387, LOT# J0454823V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU103911V| EXPLANTED: