BEUDAMED
    FDA Adverse Event Death Summary report: N

    DBS LEAD

    MDR report key: 1686035 · Received May 11, 2010

    Report

    Report Number
    6000153-2010-03856
    Event Type
    Death
    Date Received
    May 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    April 14, 2010
    Manufacturer
    MPROC, VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    THE PATIENT HAD THE LEADS IMPLANTED. THE PATIENT HAD SOME SLIGHT BLEEDING AT THE TIME OF SURGERY, BUT IT APPEARED TO BE ON THE SURFACE AND RESOLVED POST-OP. IT WAS LATER REPORTED THAT THE PATIENT DIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE ALSO MANUFACTURER'S REPORT #6000153-2010-03857.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MPROC, VILLALBA 3389S-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V345141| EXPLANTED: