BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2031486 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02135
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 18, 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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: ALLERT N, KELM S, DOHLE C, ET AL. [STIMULATOR PROGRAMMING AS PART OF HOSPITAL REHABILITATION IN DYSTONIA PTS WITH DEEP BRAIN STIMULATION]. NEUROLOGIE UND REHABILITATIONS. 2010; 16(4):186-193. SUMMARY: THE AUTHORS RETROSPECTIVELY ANALYZED THE CHANGES IN THE STIMULATION PARAMETERS THAT TOOK PLACE DURING THE REHABILITATION TREATMENT OF DYSTONIA PTS WITH DEEP BRAIN STIMULATION (DBS), THE EFFECT OF DYSTONIC MOVEMENTS ON A CLINICAL GLOBAL ASSESSMENT SCALE AND THE EFFECT ON THE EVERYDAY COMPETENCY OF PTS (AS MEASURED BY THE BARTHEL INDEX). A TOTAL OF 66 DYSTONIA PTS WITH DBS WERE HOSPITALIZED FOR 34 +/- 13 DAYS BETWEEN (B)(6) 2003 AND (B)(6) 2008. TECHNICAL DYSFUNCTIONS WERE FOUND IN TWO PTS AND A DISLOCATION OF ONE ELECTRODE IN ONE PT. EVENT: THIS FILE IS FOR THE PT WHO EXPERIENCED LEAD DISLOCATION. IT WAS REPORTED THAT ONE CERVICAL DYSTONIA PT (FEMALE) WITH BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) ELECTRODES EXPERIENCED A SIGNIFICANT REDUCTION IN SYMPTOMS FOLLOWING IMPLANTATION AT THE AGE (B)(6). SIX WEEKS FOLLOWING IMPLANTATION, THE DYSTONIC SYMPTOMS RETURNED DESPITE REPEATED ADJUSTMENTS TO THE DBS IN THE PRIMARY CENTER. A DEPRESSIVE DISORDER INCREASINGLY DEVELOPED, PSYCHOLOGICAL CARE WAS RECOMMENDED AND THE PT WAS ADMITTED TO AN IN-PATIENT REHABILITATION CENTER. FURTHER EVALUATION INDICATED THAT NO CENTRAL STIMULATION EFFECTS COULD BE GENERATED UP TO THE MAXIMUM CHARGE DENSITY; X-RAY CONFIRMED A DISLOCATION OF THE RIGHT ELECTRODE BY MORE THAN 2 CM DORSALLY. FOLLOWING ELECTRODE REVISION, THE PTS' SYMPTOMS WERE GREATLY REDUCED AND THERE WAS A RAPID RESPONSE OF THE DYSTONIA WITHIN SECONDS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO REGARDING THE PT AND EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R EXPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN| EXPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| IMPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN