BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3382248 · Received October 2, 2013

    Report

    Report Number
    3007566237-2013-03211
    Event Type
    Injury
    Date Received
    October 2, 2013
    Date of Event
    April 7, 2013
    Report Date
    September 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    POLANSKI, W., KOY, J., JURATLI, T., WOLZ, M., KLINGELHOFER, L., FAUSER, M., STORCH, A., SCHACKERT, G., SOBOTTKA, S. B. ANTICOAGULATION MANAGEMENT OF MYOCARDIAL INFARCTION AFTER DEEP BRAIN STIMULATION: A COMPARISON OF TWO CASES. ACTA NEUROCHIRURGICA. 2013;155(9):1661-1665. DOI; 10.1007/S00701-013-1679-Z. SUMMARY: DEEP BRAIN STIMULATION (DBS) IS AN ESTABLISHED TREATMENT OF VARIOUS DISEASES, PARTICULARLY USED FOR IDIOPATHIC PARKINSON¿S DISEASE. FREQUENTLY, DBS PATIENTS ARE MULTIMORBID AND MANAGING THEM MAY BE CHALLENGING, SINCE POSTOPERATIVE COMPLICATIONS CAN BECOME MORE LIKELY WITH AGE. IN THIS ARTICLE, WE PRESENT TWO CASES OF MYOCARDIAL INFARCTION AFTER DBS WITH DIFFERENT THERAPEUTIC STRATEGIES. CASE 1 WAS ANTICOAGULATED WITH A HEPARIN INFUSION WITH A TARGET PARTIAL THROMBOPLASTINE TIME (PTT) BETWEEN 50 AND 60 S AFTER THE MYOCARDIAL INFARCTION AND SHOWED 3 DAYS LATER, AFTER AN INITIAL POSTOPERATIVE INCONSPICUOUS CRANIAL COMPUTER TOMOGRAPHY, AN INTRACEREBRAL HAEMATOMA, WHICH WAS EVACUATED WITHOUT EXPLANTING THE DBS LEAD. CASE 2 WAS ONLY TREATED WITH ENOXAPARINE 40 MG S.C. TWICE A DAY AFTER THE MYOCARDIAL INFARCTION WITHOUT ANY FURTHER COMPLICATIONS. BOTH CASES BENEFITED FROM THE DBS WITH RESPECT TO THE MOTOR FLUCTUATIONS, BUT CASE 1 CONTINUED TO SUFFER FROM PSYCHOMOTOR SLOWDOWN, MILD HEMIPARESIS OF THE LEFT SIDE, VISUAL NEGLECT AND A GAZE PARESIS. UNFORTUNATELY, THERE ARE NO ESTABLISHED GUIDELINES OR THERAPY RECOMMENDATIONS FOR THE MANAGEMENT OF SUCH PATIENTS. AN INDIVIDUAL THERAPY REGIME IS NECESSARY FOR THIS PATIENT POPULATION REGARDING THE BLEEDING RISK, THE CARDIAL RISK AND THE SYMPTOMS OF THE PATIENT. RETROSPECTIVELY, THE REJECTION OF THE INTRAVENOUS APPLICATION OF HEPARIN IN CASE 2 SEEMS TO BE THE RIGHT DECISION. BUT REGARDING THE SMALL NUMBER OF CASES, IT REMAINS STILL AN INDIVIDUAL THERAPY. FURTHER EXPERIENCE WILL HELP US TO DEVELOP OPTIMAL THERAPY STRATEGIES FOR THIS PATIENT POPULATION. REPORTED EVENT: A (B)(6) WOMAN HAD A MYOCARDIAL INFARCTION AFTER DBS. THE PATIENT SUFFERED FROM CHEST PAIN WITH NON-SPECIFIC ELEVATION OF THE ST SEGMENT IN III AND AVF AND INCREASED CARDIAC ENZYMES ON THE EVENING OF THE FIRST POSTOPERATIVE DAY. AN ECHOCARDIOGRAM DEMONSTRATED MILD CONTRACTILE DYSFUNCTION OF THE LEFT VENTRICLE AND AN EJECTION FRACTION OF 55%. THE CARDIAC CATHETERIZATION ON THE SECOND POSTOPERATIVE DAY REVEALED 90% STENOSIS OF THE MILD-RIGHT CORONARY ARTERY (RCA), 90% STENOSIS OF THE MID-LEFT ANTERIOR DESCENDING ARTERY (LAD) AND 90% STENOSIS OF THE CIRCUMFLEX (CIRC) WITH AN INDICATION FOR A STENT IMPLANTATION INTO THE THREE CORONARY ARTERIES. THE PATIENT WAS PLANNED TO BE ANTICOAGULATED WITH INTRAVENOUS HEPARIN INFUSION (1000-1500 U/H) WITH A TARGET PARTIAL THROMBOPLASTINE TIME BETWEEN 50 AND 60 SECONDS. THREE DAYS LATER, THE PATIENT PRESENTED WITH SOME SOMNOLENCE AND A PARESIS OF THE LEFT ARM. CRANIAL CT SHOWED AN INTRACEREBRAL HEMATOMA AROUND THE RIGHT LEAD WITH A MILD MIDLINE DEVIATION. DURING THE PERIOD OF THE HEPARIN INFUSION, THE SYSTOLIC BLOOD PRESSURE WAS NORMAL. HEPARIN INFUSION WAS STOPPED AND CONTROL CT REVEALED A GENTLE INCREASE OF THE INTRACRANIAL HEMATOMA. BECAUSE OF THE ELEVATED PTT OF 66 SECONDS, HEPARIN WAS ANTAGONIZED WITH PROTAMINE AND THE EVACUATION OF THE HEMATOMA WAS PERFORMED ON THE 10TH POSTOPERATIVE DAY WITHOUT EXPLANTATION OF THE LEAD, ALTHOUGH THE POSITION OF BOTH LEADS WAS ALTERED DUE TO THE BRAIN SHIFT. THE CT SHOWED A CHANGED POSITION OF THE LEFT LEAD 3.1 MM TO POSTERIOR AND A CHANGED POSITION OF THE RIGHT LEAD 2.9 MM POSTERIOLATERAL. AFTER 3 MONTHS, PCI WAS PERFORMED WITH BARE-METAL STENTS WITHOUT COMPLICATIONS. POST PROCEDURE, THE PATIENT WAS TREATED WITH CLOPIDOGREL. SHE BENEFITTED FROM DBS WITH RESPECT TO MOTOR FLUCTUATIONS AND REMAINED FREE OF ANGINA PECTORIS. IT WAS NOTED THAT THE POSITION SHIFT WAS DUE TO MASSIVE BRAIN SHIFT CAUSED BY THE BLEEDING AND NOT DUE TO A REAL SHIFT OF THE LEAD OUT OF THE TARGET. IT WAS STATED THAT THE PATIENT CONTINUED TO SUFFER FROM PSYCHOMOTOR SLOWDOWN, MILD HEMIPARESIS OF THE LEFT SIDE, VISUAL NEGLECT, AND A GAZE PARESIS. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO MALFUNCTIONS AND NO DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497931 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention