BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2101918 · Received May 18, 2011

    Report

    Report Number
    3004209178-2011-03619
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 20, 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
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A CONSTANT SHOCKING OR JOLTING SENSATION ON THE LEFT SIDE OF HER BODY FROM HER HEAD TO HER TOES FOLLOWING A FALL. SHE HAD FALLEN ABOUT A WEEK EARLIER AND HAD HIT HER HEAD. SHE REPORTED THAT MOVEMENT CAUSED CHANGES IN HER STIMULATION. FIVE DAYS LATER THE PT REPORTED INTERMITTENT "BUZZING" ON HER ENTIRE LEFT SIDE AFTER A BOLT OF LIGHTNING STRUCK OUTSIDE NEXT TO THE WINDOW WHERE SHE WAS SITTING. THE PT DID NOT REPORT ANY ELECTRICAL ISSUES INSIDE THE HOUSE DURING THE LIGHTNING STRIKE. THE PT DESCRIBED HER STATUS AS GOOD. FOLLOW-UP WITH THE PT'S HEALTHCARE PROFESSIONAL WAS RECOMMENDED. 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 66 YR Female EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0084737N.| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# N25030A.| EXTENSION: MODEL 7495-51, LOT# XR0084737N| LEAD: MODEL 3387, LOT# N25030A| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: