BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2419555 · Received December 19, 2011

    Report

    Report Number
    3007566237-2011-09268
    Event Type
    Malfunction
    Date Received
    December 19, 2011
    Report Date
    November 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: CAPELLE, H.H. KINFE, T.M., KRAUSS, J.K. DEEP BRAIN STIMULATION FOR TREATMENT OF HEMICHOREA-HEMIBALLISM AFTER CRANIOP HARYNGIOMA RESECTION: LONG-TERM FOLLOW-UP. JOURNAL OF NEUROSURGERY 2011. 115: 966-970. PUBLISHED ONLINE AUGUST 5, 2011. DOI: 10.3171/2011/6.JNS101388. SUMMARY: SUMMARY: THE AUTHORS REPORT ON THE EFFECTIVENESS OF DEEP BRAIN STIMULATION IN A PATIENT WITH HEMICHOREA-HEMIBALLISM THAT DEVELOPED FOLLOWING RESECTION OF A CRANIOPHARYNGIOMA. THE PATIENT WAS IMPLANTED BOTH IN THE THALMIC VENTRALIS INTERMEDIUS NUCLEUS AND THE POSTEROVENTRAL LATERAL GLOBUS PALLIDUS INTERNUS AND THE ENERGY CONSUMPTION AS IT RELATES TO THALMIC VS PALLIDAL STIMULATION WAS DISCUSSED. REPORTABLE EVENT: AT 19 MONTHS POST-OPERATIVELY THERE WAS A SUDDEN REOCCURRENCE OF THE CHOREIC MOVEMENTS AFTER THE PATIENT CHANGED AN ELECTRIC BULB. INTERROGATION OF THE PACEMAKER REVEALED THAT IT WAS SWITCHED OFF. AFTER RESETTING THE STIMULATION THE CHOREIC MOVEMENTS DISAPPEARED WITHIN MINUTES, AT AN AMPLITUDE OF 0.8V. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY - STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN MHY MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1