BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2120144 · Received June 6, 2011

    Report

    Report Number
    3007566237-2011-03998
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    November 4, 2008
    Report Date
    June 24, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: ALI Z, PRABHAKAR H, RATH GP, DASH HH. ENOXAPARIN INDUCED INTRACEREBRAL HAEMORRHAGE AFTER DEEP BRAIN STIMULATION SURGERY. EUR J ANAESTHESIOL. JUL 2009:26(7):617-618. SUMMARY: THIS ARTICLE DISCUSSED A CASE OF ANTICOAGULANT (ENOXAPARIN) INDUCED INTRACEREBRAL HEMORRHAGE IN THE POST-OPERATIVE PERIOD IN A (B)(6) MALE PARKINSON'S DISEASE PT WHO UNDERWENT BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) SURGERY. THE PT HAD A HISTORY OF TREMULOUSNESS OF THE RIGHT UPPER LIMB AND BOTH LOWER LIMBS ASSOCIATED WITH SLUGGISHNESS OF MOVEMENTS, DECREASED VOLUME AND SLURRING SPEECH FOR THREE YEARS, AFTER WHICH OVER A PERIOD OF 6 MONTHS, THE PT'S SYMPTOMS PROGRESSED AND EXAMINATION REVEALED HYPERTONIA, BRADYKINESIA, RIGIDITY, AND POSTURAL INSTABILITY. THE PT ALSO HAD A HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE, AND SUBDURAL HEMATOMA. EVENT: FOLLOWING THE SECOND STAGE OF THE STN-DBS SURGERY DURING WHICH THE STIMULATOR WAS IMPLANTED AND DURING WHICH THE PT HAD MECHANICAL VENTILATION, THE PT'S TRACHEA WAS EXTUBATED AND THE PT WAS MOVED TO THE ICU. ON THE FIFTH POST-OPERATIVE DAY, 40 MG OF ENOXAPARIN WAS ADMINISTERED TO PREVENT DEEP VEIN THROMBOSIS. THE PT BECAME UNRESPONSIVE WITHIN A FEW HOURS OF ADMINISTRATION. THE PT WAS REINTUBATED AND TAKEN FOR A CT SCAN WHICH REVEALED AN INTRACEREBRAL HEMATOMA IN THE LEFT BASAL GANGLION AND LEFT FRONTO-PARIETAL REGION WITH MIDLINE SHIFT AND PERILESIONAL EDEMA. PROTHROMBIN TIME AND ACTIVATED PARTIAL THROMBOPLASTIN TIME WERE PROLONGED WITH A NORMAL PLATELET COUNT. ENOXAPARIN WAS DISCONTINUED AND SIX UNITS OF FRESH FROZEN PLASMA WERE TRANSFUSED, WHILE MECHANICAL VENTILATION WAS CONTINUED. THE PT'S COAGULATION STATUS RETURNED TO NORMAL WITHIN THE NEXT FOUR DAYS, AND THERE WAS AN IMPROVEMENT IN NEUROLOGICAL STATUS. THE HEMATOMA HAD RESOLVED AND WAS NOT EXPANDING SO NO EVACUATION WAS PERFORMED. THE PT THEN DEVELOPED VENTILATOR-ASSOCIATED PNEUMONIA AND SEPSIS DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS ON POST-OPERATIVE DAY 25. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME, NO ADDITIONAL INFO WAS AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 75 YR Life Threatening EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| LEAD: MODEL UNK, LOT# UNK| IMPLANTED: