BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1822584 · Received August 27, 2010

    Report

    Report Number
    3007566237-2010-06539
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    June 29, 2010
    Report Date
    February 8, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE LEAD, THE PT DEVELOPED INTRAVENTRICULAR BLEEDING. THE PHYSICIAN ATTEMPTED TO PLACE A SHUNT BUT THAT PRODUCED MORE BLEEDING. IT WAS NOTED THAT THE PT WAS TAKING MULTIPLE OVER-THE-COUNTER HERBS. THE PT'S OUTCOME WAS REPORTED AS OKAY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention EXPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL DBSLEAD, LOT# UNK| EXPLANTED:| UNK CONVERSION TYPE: MODEL DBSLEAD, LOT# UNK| IMPLANTED: