BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1511288 · Received October 13, 2009

    Report

    Report Number
    2182207-2009-07308
    Event Type
    Injury
    Date Received
    October 13, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 5, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: COLEY E, FARHADI R, LEWIS S, WHITTLE IR. THE INCIDENCE OF SEIZURES FOLLOWING DEEP BRAIN STIMULATING ELECTRODE IMPLANTATION FOR MOVEMENT DISORDERS, PAIN AND PSYCHIATRIC CONDITIONS. BR J NEUROSURG. 2009; 23(2): 179-183. SUMMARY: THIS ARTICLE PRESENTS A LITERATURE REVIEW OF 32 PAPERS FOUND USING A SEARCH STRATEGY TRAWLING THROUGH PAPERS DESCRIBING CLINICAL CASE SERIES OF DBS THAT DESCRIBED STEREOTACTIC PLACEMENT OF DBS ELECTRODES FOR MOVEMENT DISORDERS, PAIN SYNDROME, AND PSYCHIATRIC CONDITIONS WITH COHORTS OF N>5. THE AIM OF THE STUDY WAS TO PROVIDE ESTIMATES OF THE PROCEDURAL RELATED SEIZURES OR EPILEPSY FOLLOWING CHRONIC DBS FOR MOVEMENT DISORDERS, PAIN, AND PSYCHIATRIC CONDITIONS. REPORTABLE EVENT: ONE PT EXPERIENCED DELAYED CHRONIC SEIZURE DISORDER FOLLOWING BILATERAL GPI DBS IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXTENSION: MODEL UNK, LOT # UNK| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: