BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3382252 · Received October 2, 2013

    Report

    Report Number
    3007566237-2013-03212
    Event Type
    Injury
    Date Received
    October 2, 2013
    Date of Event
    April 7, 2013
    Report Date
    September 4, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. B.5. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION TO MANUFACTURING SITE: MANUFACTURING SITE OF 3007566237 SHOULD BE CORRECTED TO (B)(4) DUE TO NEW DEVICE SERIAL NUMBERS.

    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) MAN HAD A MYOCARDIAL INFARCTION AFTER DBS. ON THE 14TH POSTOPERATIVE DAY, HE DEVELOPED ANGINA PECTORIS WITH NON-SPECIFIC ELEVATED ST SEGMENT IN III AND AVF, AS WELL AS INCREASED CARDIAC ENZYMES. THE ECHOCARDIOGRAM SHOWED A POSTEROBASAL AKINESIA WITH AN EJECTION FRACTION OF 55%. CARDIAC CATHETERIZATION ON THE 15TH POSTOPERATIVE DAY DEMONSTRATED 90% STENOSIS OF THE LAD, 90% STENOSIS OF THE CIRC, AND A COMPLETE OCCLUSION OF THE RCA. THE PATIENT WAS TREATED WITH ENOXAPARINE 40 MG S.C. TWICE A DAY. THREE WEEKS LATER THE PATIENT DEVELOPED AN INSTABLE ANGINA PECTORIS. A NEW CARDIAC CATHETERIZATION WITH ANGIOPLASTY WAS PERFORMED, WHICH REVEALED A 75% STENOSIS OF LAD AND A 50% STENOSIS OF CIRC, WHILE THE RCX REMAINED OCCLUDED. POST PROCEDURE, THE PATIENT WAS TREATED WITH CLOPIDOGREL AND LONG-TERM WITH ASPIRIN. HE BENEFITED FROM DBS WITH RESPECT TO THE MOTOR FLUCTUATIONS AND CONTINUED TO BE FREE OF ANGINA PECTORIS. 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
    497678 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention