BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD (L-SIDED)

    MDR report key: 1000057 · Received February 15, 2008

    Report

    Report Number
    2182207-2008-00707
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 16, 2008
    Manufacturer
    NEUROLOGICAL DIVISION, MEDTRONIC, INC.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE REPRESENTATIVE REPORTED THAT TWO DBS LEADS HAD BEEN PLACED FOR A STAGE 1, DBS LEAD IMPLANT PROCEDURE. THE FOLLOWING DAY THE PATIENT HAD ONE SEIZURE IN THE HOSPITAL; IT WAS UNCONFIRMED IF IT HAD BEEN A GRAND MAL SEIZURE OR IF THE PATIENT HAD A HISTORY OF SEIZURES. THE PHYSICIAN SUSPECTED SWELLING AT THE LEFT LEAD IMPLANT SITE IN THE BRAIN; MRI TESTING WAS CONSIDERED AND COMPATABILITY INFORMATION HAD BEEN REVIEWED. DURING IMPLANT, END CAPS AND ACCESSORY BOOTS HAD BEEN PLACED AT THE PROXIMAL END OF BOTH LEADS. THE INS WAS NOT IMPLANTED. THE PATIENT HAD BEEN DISCHARGED TO HOME FROM THE HOSPITAL; HE WAS "DOING OK, BUT WAS STILL A LITTLE FOGGY FROM THE EVENTS" AT THE TIME OF HIS RELEASE. DEVICE SPECIFIC INFORMATION WAS NOT AVAILABLE AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD (L-SIDED) MHY NEUROLOGICAL DIVISION, MEDTRONIC, INC. 3389 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXPLANTED:| IMPLANTED:| DBS LEAD MODEL 3389 LOT#UNK