BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1950335 · Received December 14, 2010

    Report

    Report Number
    3007566237-2010-10433
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A DBS PATIENT BEING TREATED FOR (B)(6) DISEASE HAD BEEN HAVING THE LEADS "SHORT CIRCUIT". THE THERAPY HAD WORKED WELL IN MITIGATING THE SYMPTOMS UNTIL THE ISSUE WITH THE LEADS. THE PATIENT WAS SCHEDULED TO UNDERGO SURGERY OVER THANKSGIVING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN