BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBS LEAD (2)

    MDR report key: 883768 · Received July 20, 2007

    Report

    Report Number
    6000153-2007-02352
    Event Type
    Injury
    Date Received
    July 20, 2007
    Report Date
    June 22, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT HER SON IS NOT DOING WELL, STATING THAT HIS SYMPTOMS HAVE RETURNED; HE APPEARS STIFF, HAS BEEN SWEATING AND HAS IMPAIRED SPEECH. SHE THINKS THE DEVICE IS NOT WORKING ANYMORE. HER SON'S PREVIOUS DOCTOR HAS DISCONTINUED MEDICAL PRACTICE; THEY ARE NOT CURRENTLY ESTABLISHED WITH A PHYSICIAN. THE PRESENTATIVE PROVIDED A LIST OF REFERRAL PHYSICIANS AND REDIRECTED THE FAMILY MEMBER TO OBTAIN MEDICAL CONSULTATION FOR THE IMPLANTED DBS SYSTEM TO BE CHECKED USING A CLINICIAN PROGRAMMER, AND MAY BE REPROGRAMMED AT FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD (2) MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 3387 J0555411V

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other IMPLANTABLE NEURO STIMULATOR MODEL 7426| IMPLANTABLE NEURO STIMULATOR MODEL 7426| EXTENSION MODEL 7482 LOT#NHU114633V IMPLANTED:| EXPLANTED:| LEAD MODEL 3387 LOT# J0555411V IMPLANTED:| EXPLANTED:| LOT# NFW131935H IMPLANTED:| EXPLANTED:| LOT# NFW131936H IMPLANTED:| EXPLANTED:| EXTENSION MODEL 7482 LOT#NHU114632V IMPLANTED:| EXPLANTED: