BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2887816 · Received December 27, 2012

    Report

    Report Number
    3007566237-2012-03134
    Event Type
    Death
    Date Received
    December 27, 2012
    Date of Event
    January 24, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS AN ESTIMATE AS THE ACTUAL DATE WAS NOT PROVIDED. 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. ADD'L DEVICES: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: FRANZINI, A., CORDELLA, R., MESSINA, G., MARRAS, C. E., ROMITO, L. M., ALBANESE, A., RIZZI, M., NARDOCCI, N., ZORZI, G., ZEKAJ, E., VILLANI, F., LEONE, M., GAMBINI, O., BROGGI, G. TARGETING THE BRAIN: CONSIDERATIONS IN 332 CONSECUTIVE PATIENTS TREATED BY DEEP BRAIN STIMULATION (DBS) FOR SEVERE NEUROLOGICAL DISEASES. NEUROLOGICAL SCIENCES : OFFICIAL JOURNAL OF THE ITALIAN NEUROLOGICAL SOCIETY AND OF THE ITALIAN SOCIETY OF CLINICAL NEUROPHYSIOLOGY. 2012;33(6):1285-1303. DOI: 10.1007/S10072-012-0937-9. SUMMARY: DEEP BRAIN STIMULATION (DBS) EXTENDS THE TREATMENT OF SOME SEVERE NEUROLOGICAL DISEASES BEYOND PHARMACOLOGICAL AND CONSERVATIVE THERAPY. OUR EXPERIENCE EXTENDS THE FIELD OF DBS BEYOND THE TREATMENT OF PARKINSON DISEASE AND DYSTONIA, INCLUDING SEVERAL OTHER DISEASES SUCH AS CLUSTER HEADACHE AND DISRUPTIVE BEHAVIOR. SINCE 1993, AT THE ISTITUTO NAZIONALE NEUROLOGICO "CARLO BESTA" IN MILAN, 580 DEEP BRAIN ELECTRODES WERE IMPLANTED IN 332 PATIENTS. THE DBS TARGETS INCLUDE STN, GPI, VOA, VOP, VIM, CM-PF, PHYP, CZI, NACC, IC, PPN, AND BRODMANN AREAS 24 AND 25. THREE HUNDRED PATIENTS ARE STILL AVAILABLE FOR FOLLOW-UP AND THERAPEUTIC CONSIDERATIONS. DBS GAVE A NEW THERAPEUTIC CHANCE TO THESE PATIENTS AFFECTED BY SEVERE NEUROLOGICAL DISEASES AND IN SOME CASES CONTROLLED LIFE-THREATENING PATHOLOGICAL CONDITIONS, WHICH WOULD OTHERWISE RESULT IN THE DEATH OF THE PATIENT SUCH AS IN STATUS DYSTONICUS, STATUS EPILEPTICUS AND POST-STROKE HEMIBALLISMUS. THE BALANCE OF DBS IN SEVERE NEUROLOGICAL DISEASE IS STRONGLY POSITIVE EVEN IF FURTHER INVESTIGATIONS AND STUDIES ARE NEEDED TO SEARCH FOR NEW APPLICATIONS AND REFINE THE SELECTION CRITERIA FOR THE ACTUAL INDICATIONS. REPORTED EVENTS: MASSIVE BRAIN HEMORRHAGE WITH FATAL OUTCOME OCCURRED IN TWO CASES OF STN IMPLANT. TWO PATIENTS WITH SUBTHALAMIC NUCLEUS STIMULATION (STN) HAD A BRAIN HEMATOMA WITH HEMIPLEGIA. ONE PATIENT WITH STN STIMULATION PRESENTED AN UNEXPLAINED FRACTURE OF THE EXTRACANIC PORTION OF THE LEAD AND UNDERWENT SUCCESSFUL RE-IMPLANT. TWO PATIENTS WITH STN STIMULATION HAD MONOLATERAL STIMULATION SYSTEM REMOVAL DUE TO INFECTION. IN ONE PEDIATRIC PATIENT SUFFERING FROM A SEVERE FORM OF SECONDARY DYSTONIA WHO WAS SUCCESSFULLY TREATED BY GLOBUS PALLIDUS PARS INTERNA (GPI) DBS 2 YEARS PREVIOUSLY, THE STIMULATION DEVICE ON THE RIGHT SIDE BECAME INFECTED BECAUSE OF THE SKIN EROSION OF THE HEAD ALONG THE PATH OF THE CONNECTOR. CONSIDERING THE RISK OF RELAPSE OF EROSION, BECAUSE OF THE THINNESS OF THE PATIENT, A RIGHT PALIDOTOMY WAS THEN PERFORMED BY THE DBS ELECTRODE, BEFORE ITS SUBSEQUENT, DEFINITIVE REMOVAL. A LONG-LASTING STABLE CONTROL OF DYSTONIA WAS OBSERVED, AND 9 MONTHS AFTER THE LESIONING PROCEDURE, WITH THE LEFT DBS ELECTRODE STILL ACTIVE, THE BFMDRS WAS THE SAME AS THAT RECORDED WITH BILATERAL STIMULATION. THE EVENT WAS SUCCESSFULLY MANAGED. HARDWARE MIGRATION OF THE ELECTRODE IN 4 CASES OF GPI STIMULATION. THE EVENTS WERE SUCCESSFULLY MANAGED. BREAKING OF THE ELECTRODE IN 2 CASES OF GPI STIMULATION. THE EVENT WAS SUCCESSFULLY MANAGED. ONE PATIENT WITH GPI STIMULATION HAD DISLODGEMENT OF THE LEFT ELECTRODE TO A POSITION CLOSE TO THE LEFT AMYGDALA AND DEVELOPED BEHAVIORAL CHANGES CONSISTING OF DEPRESSION, PSYCHOTIC SYMPTOMS AND HEIGHTENED PAIN PERCEPTION RELATED TO THE SURGICAL PROCEDURE. INFECTION IN 5 CASES OF GPI STIMULATION. THE EVENTS WERE SUCCESSFULLY MANAGED. INTRACRANIAL HEMORRHAGE IN ONE CASE OF GPI STIMULATION. THE HEMORRHAGE WAS NOT SUCCESSFULLY MANAGED. THE LAST OCD PATIENT OF OUR SERIES HAD BILATERAL STIMULATION OF THE VENTRAL STRIATUM CLOSE TO THE BNST, AND HE ALSO OBTAINED SIGNIFICANT REDUCTION IN OCD SYMPTOMS AT THE 1-YEAR FOLLOW UP WHEN THE PREMATURE EXHAUSTION OF THE IPG RESULTED IN THE RECURRENCE OF DISEASE. PERMANENT NEUROLOGICAL DEFICITS DUE TO DEEP HEMORRHAGE OCCURRED IN 6 PATIENTS OF WHOM ONE WAS A VIM IMPLANT AND THE OTHER STN IMPLANT. TRANSIENT NEUROLOGICAL DEFICITS DUE TO DEEP HEMORRHAGE OCCURRED IN EIGHT PATIENTS. POSTOPERATIVE SEIZURES IN SEVEN PATIENTS. HARDWARE REMOVAL DUE TO INFECTION IN 32 CASES. HARDWARE REMOVAL DUE TO INFECTION WITH CEREBRAL ABSCESS AT THE ORIGIN OF THE STEREOTACTIC TRAJECTORY IN 6 CASES. HARDWARE FAILURE IN 30 PATIENTS. LATE ELECTRODE MIGRATION IN 20 PATIENTS. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R