BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1822585 · Received August 27, 2010

    Report

    Report Number
    3004209178-2010-06538
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 29, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    FOLLOWING IMPLANT, THE PT COULD TALK TO THE DOCTOR AND "THE SYMPTOM WAS GETTING WELL". AT 8 PM, THE PT WAS IN COMA; THE DOCTOR FOUND "THE PT GOT CEREBRAL HEMORRHAGE". THE DOCTOR DID DRAINAGE SURGERY, BUT THE PT WAS STILL IN COMA AND PARALYZED ON THE LEFT SIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S