BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DBS LEAD

    MDR report key: 1895337 · Received November 8, 2010

    Report

    Report Number
    3007566237-2010-08997
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A CRANIAL HEMORRHAGE OCCURRED. DURING THE IMPLANT, IT WAS NOTICED THAT THE PT EXHIBITED A "BACKFLOW" OF BLOOD FROM THE INSERTION TUBE. THE PT RESPONDED WELL TO THE PHYSICIAN'S EVALUATION, SO THE DOCTORS DECIDED THAT THEY WOULD CONTINUE WITH THE CASE. A PERMANENT LEAD WAS PLACED IN THE PT'S RIGHT HEMISPHERE AFTER 3 MICROELECTRODE RECORDING (MER) PASSES. A SECOND PERMANENT LEAD WAS THEN PLACED IN THE PT'S LEFT HEMISPHERE AFTER 2 MER PASSES. AFTER THE PROCEDURE, A CT SCAN WAS PERFORMED, AND IT SHOWED A 6 SONOMETER CRANIAL HEMORRHAGE JUST BELOW THE DURA IN THE LEFT HEMISPHERE. NO INTERVENTION WAS REQUIRED, AND THE PT RECOVERED IN THE HOSPITAL AFTER ONE WEEK OF REST. THE PT WAS DOING "WELL," AND THERE WAS NO OBVIOUS BRAIN DAMAGE OR MENTAL INCAPACITATION AS A RESULT OF THE HEMORRHAGE BECAUSE THE BLEED OCCURRED IN A "QUIET" AREA OF THE BRAIN. REFER TO MFR REPORT # 3007566237201008996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MEDTRONIC NEUROMODULATION 3389S-40 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention LEAD: MODEL 3389S-40, LOT# UNK| EXPLANTED:| IMPLANTED: