BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2181454 · Received July 6, 2011

    Report

    Report Number
    3004209178-2011-05127
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 10, 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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED DIZZINESS, LETHARGY, AND A CHANGE IN HIS GAIT. THE SYMPTOMS OCCURRED DURING THE MIDDLE OF A SEVERE THUNDER AND LIGHTENING STORM AND LASTED ABOUT 10 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE ALSO MANUFACTURER'S REPORT #3004209178201105128.

    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 62 YR PROGRAMMER: MODEL 7438, LOT# NHL025153P| EXPLANTED:| LEAD: MODEL 3387S, LOT# V187428| LEAD: MODEL 3387S, LOT# V199750| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU186488V| LOT# NFW151952H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU176175V| IMPLANTED:| IMPLANTED:| IMPLANTED: