BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3230211 · Received July 16, 2013

    Report

    Report Number
    3007566237-2013-02368
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    October 17, 2011
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # 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. 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 (B)(4), (B)(4) DEEP BRAIN ELECTRODES WERE IMPLANTED IN 332 PATIENTS. TWO HUNDRED SEVENTY SIX (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 DYSTONICS, 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 EVENT: 1 PATIENT SUFFERING FROM DYSTONIA HAD BILATERAL IMPLANTATION OF DEEP BRAIN STIMULATION (DBS) SYSTEM IN THE GLOBUSPAL LIDUS INTERNA (GPI) AND HAD DISLODGEMENT OF THE ELECTRODE TO A POSITION CLOSE TO THE AMYGDALA. IT WAS NOTED THAT HE DEVELOPED BEHAVIORAL CHANGES CONSISTING OF DEPRESSION, PSYCHOTIC SYMPTOMS, AND HEIGHTENED PAIN PERCEPTION. IT WAS NOTED THAT THE COMPLICATION WAS SUCCESSFULLY MANAGED. 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
    328856 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability