BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3233746 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02401
    Event Type
    Death
    Date Received
    July 18, 2013
    Report Date
    October 17, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FRANZINI, A., CORDELLA, R., MESSINA, G., MARRAS, C. E., ROMITO, L. M., CARELLA, F., ALBANESE, A., RIZZI, M., NARDOCCI, N., ZORZI, G., ZEKAY, E., BROGGI, G. DEEP BRAIN STIMULATION FOR MOVEMENT DISORDERS. CONSIDERATIONS ON 276 CONSECUTIVE PATIENTS. J NEURAL TRANSM.2 011;118(10):1497-1510. DOI: 10.1007/S00702-011-0656-Z. SUMMARY: THE LINKS BETWEEN STN DBS AND ADVANCED PARKINSON DISEASE, AND BETWEEN GPI DBS AND DYSTONIA ARE NEARLY UNIVERSALLY ACCEPTED BY THE NEUROLOGISTS AND NEUROSURGEONS. NEVERTHELESS, IN SOME CONDITIONS,TARGETS SUCH AS THE VENTRAL THALAMUS AND THE ZONA INCERTA MAY BE CONSIDERED TO OPTIMIZE THE RESULTS AND AVOID THE SIDE EFFECTS. POSITIVE AND NEGATIVE ASPECTS OF CURRENT DBS TREATMENTS JUSTIFY THE RESEARCH OF NEW TARGETS, NEW STIMULATION PROGRAMS AND NEW HARDWARE. SINCE 1993, AT THE ISTITUTO NAZIONALE NEUROLOGICO ¿¿CARLO BESTA¿¿ IN MILAN, 580 DEEP BRAIN ELECTRODES WERE IMPLANTED IN 332 PATIENTS. 276 PATIENTS WERE AFFECTED BY MOVEMENT DISORDERS. THE DBS TARGETS INCLUDED STN, GPI, VOA, VOP, VIM, CM¿PF, CZI, IC. THE LONG-TERM FOLLOW-UP IS REPORTED AND RELATED TO THE CHOSEN TARGET. DBS GAVE A NEW THERAPEUTIC OPTION TO PATIENTS AFFECTED BY SEVERE MOVEMENT DISORDERS, AND IN SOME CASES RESOLVED LIFE-THREATENING PATHOLOGICAL CONDITIONS THAT WOULD OTHERWISE RESULT IN THE DEATH OF THE PATIENT, SUCH AS IN STATUS DYSTONICUS, AND POST-STROKE HEMIBALLISM US. NEVERTHELESS, THE POTENTIAL OCCURRENCE OF SEVERE COMPLICATIONS STILL LIMIT A WIDER USE OF DBS. AT TODAY, THE USE OF DBS IN SEVERE MOVEMENT DISORDERS IS STRONGLY POSITIVE EVEN IF FURTHER INVESTIGATIONS AND STUDIES ARE NEEDED TO UNVEIL POTENTIAL NEW APPLICATIONS, AND TO REFINE THE SELECTION CRITERIA FOR THE ACTUAL INDICATIONS AND TARGETS. THE EXPERIENCE OF DIFFERENT TARGETS MAY BE USEFUL TO GUIDE AND TAILOR THE TARGET CHOICE TO THE INDIVIDUAL CLINICAL CONDITION. REPORTED EVENTS: 1. 2 PATIENTS HAD A MASSIVE BRAIN HEMORRHAGE WITH A FATAL OUTCOME. 2. 6 PATIENTS HAD PERMANENT NEUROLOGICAL DEFICITS DUE TO DEEP HEMORRHAGE 3. 8 PATIENTS HAD TRANSIENT NEUROLOGICAL DEFICITS DUE TO DEEP HEMORRHAGE. 4. 7 PATIENTS HAD POST-OPERATIVE SEIZURES. 5. 26 PATIENTS HAD HARDWARE REMOVED DUE TO INFECTION. 6. 6 PATIENTS HAD HARDWARE REMOVED DUE TO INFECTION AND HAD A CEREBRAL ABSCESS AT THE ORIGIN OF THE STEREOTACTIC TRAJECTORY. 7. 30 PATIENTS HAD A HARDWARE FAILURE. 8. 20 PATIENTS HAD A LATE ELECTRODE MIGRATION. 9. 2 PATIENTS WITH PARKINSON¿S DISEASE HAD A BILATERAL DEEP BRAIN STIMULATION (DBS) IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) DID NOT HAVE AN IMPROVEMENT IN THEIR SPEECH ITEM, WEIGHT GAIN, AND HAD A BRAIN HEMATOMA WITH HEMIPLEGIA. 10. 1 PATIENTS WITH PARKINSON¿S DISEASE HAD A BILATERAL DEEP BRAIN STIMULATION (DBS) IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) DID NOT HAVE AN IMPROVEMENT IN THEIR SPEECH ITEM, WEIGHT GAIN, AND HAD PRESENTED AN UNEXPLAINED FRACTURE OF THE EXTRACRANIC PORTION OF THE LEAD. IT WAS NOTED THAT THE PATIENT UNDERWENT A SUCCESSFUL LEAD REPLACEMENT. 11. 2 PATIENTS WITH PARKINSON¿S DISEASE HAD A BILATERAL DEEP BRAIN STIMULATION (DBS) IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) DID NOT HAVE AN IMPROVEMENT IN THEIR SPEECH ITEM, WEIGHT GAIN, AND HAD MONOLATERAL REMOVAL OF THEIR SYSTEMS DUE TO INFECTION. 12. 17 PATIENTS WITH PARKINSON¿S DISEASE HAD A BILATERAL DEEP BRAIN STIMULATION (DBS) IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) DID NOT HAVE AN IMPROVEMENT IN THEIR SPEECH ITEM, WEIGHT GAIN, AND HAD HYPOPHONIA. 13. 11 PATIENTS WITH PARKINSON¿S DISEASE HAD A BILATERAL DEEP BRAIN STIMULATION (DBS) IMPLANTED IN THE SUBTHALAMIC NUCLEUS (STN) DID NOT HAVE AN IMPROVEMENT IN THEIR SPEECH ITEM, WEIGHT GAIN, AND HAD DYSARTHRIA. 14. 1 PEDIATRIC PATIENT SUFFERING FROM A SEVER FROM OF SECONDARY DYSTONIA HAD BILATERAL IMPLANTATION OFDEEP BRAIN STIMULATION (DBS) SYSTEM IN THE GLOBUS PALLIDUS INTERNA (GPI) AND WAS SUCCESSFULLY TREATED FOR 2 YEARS BEFORE THE STIMULATION DEVICE ON THE RIGHT SIDE BECAME INFECTED BECAUSE OF SKIN EROSION OF THE HEAD ALONG THE PATH OF THE CONNECTOR. IT WAS NOTED THAT A RIGHT PALLIDOTOMY WAS PERFORMED BY THE DBS ELECTRODE BEFORE ITS SUBSEQUENT DEFINITIVE REMOVAL. 15. 4 PATIENTS SUFFERING FROM DYSTONIA HAD BILATERAL IMPLANTATION OF DEEP BRAIN STIMULATION (DBS) SYSTEM IN THE GLOBUS PALLIDUS INTERNA (GPI) AND HAD MIGRATION OF THE ELECTRODE. IT WAS NOTED THAT THE COMPLICATION WAS SUCCESSFULLY MANAGED. 16. 2 PATIENTS SUFFERING FROM DYSTONIA HAD BILATERAL IMPLANTATION OF DEEP BRAIN STIMULATION (DBS) SYSTEM IN THE GLOBUS PALLIDUS INTERNA (GPI) AND HAD BREAKAGE OF THE ELECTRODE. IT WAS NOTED THAT THE COMPLICATION WAS SUCCESSFULLY MANAGED. 17. 5 PATIENTS SUFFERING FROM DYSTONIA HAD BILATERAL IMPLANTATION OF DEEP BRAIN STIMULATION (DBS) SYSTEM IN THE GLOBUS PALLIDUS INTERNA (GPI) AND HAD AN INFECTION. IT WAS NOTED THAT THE COMPLICATION WAS SUCCESSFULLY MANAGED. 18. 1 PATIENT SUFFERING FROM DYSTONIA HAD BILATERAL IMPLANTATION OF DEEP BRAIN STIMULATION (DBS) SYSTEM IN THE GLOBUS PALLIDUS INTERNA (GPI) AND HAD AN INTRACRANIAL HEMORRHAGE. 19. 4 PATIENT SUFFERING FROM PARKINSON¿S DISEASE WITH LEVODOPA INDUCED DYSKINESIA DEVELOPED SEVERE AKINESIA RESISTANT TO LEVODOPA THERAPY AFTER 4 YEARS OF CHRONIC STIMULATION. 20. 3 PATIENTS HAD BILATERAL THALAMIC IMPLANTS AND HAD SPEECH IMPAIRMENT. 21. 3 PATIENTS WITH SEVERE SYNDROMES CHARACTERIZED BY HIGH AMPLITUDE DISTRESSING TREMOR OF BILATERAL LIMBS AND HEAD, AND WERE COMPLETELY INVALID. IT WAS FURTHER REPORTED THAT THESE PATIENTS DID NOT HAVE RESTORATION OF FINALISTIC MOVEMENTS AND BILATERAL SURGERY WAS ASSOCIATED WITH SPEECH IMPAIRMENT. 22. 1 PATIENT WITH SEVERE SYNDROMES CHARACTERIZED BY HIGH AMPLITUDE DISTRESSING TREMOR OF BILATERAL LIMBS AND HEAD, AND WAS COMPLETELY INVALID. IT WAS FURTHER REPORTED THAT THIS PATIENT DID NOT HAVE RESTORATION OF FINALISTIC MOVEMENTS AND BILATERAL SURGERY WAS ASSOCIATED WITH SPEECH IMPAIRMENT. ADDITIONALLY IT WAS NOTED THAT SURGERY WAS FOLLOWED BY A RELAPSE OF THE DEMYELINATING DISEASE. 23. 19 PATIENTS AFFECTED BY ADVANCED PARKINSON¿S DISEASE HAD BILATERAL IMPLANTS IN THE PRE-LEMNISCAL RADIATION (RAPRL) AND HAD AN INCIDENT OF SPEECH IMPAIRMENT OF 36% AND DEPRESSION OF 18%. 24. 4 PATIENTS AFFECTED BY ADVANCED PARKINSON¿S DISEASE HAD ASYMMETRICAL IMPLANTS IN THE PRE-LEMNISCAL RADIATION (RAPRL) AND IN THE CAUSAL ZONA INCERTA (CZI) ON THE CONTRALATERAL SIDE AND HAD AN INCIDENT OF SPEECH IMPAIRMENT OF 36% AND DEPRESSION OF 18%. PLEASE REFER TO MANUFACTURES REPORT # 3007566237-2013-02368 FOR ADDITIONAL INFORMATION ON A RELATED EVENT. 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
    336199 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Death| R| S