BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1895269 · Received November 8, 2010

    Report

    Report Number
    3007566237-2010-09026
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    April 1, 2010
    Report Date
    October 6, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    HARDWARE ADVERSE EVENTS IN A SERIES OF 141 PATIENTS UNDERGOING SUBTHALAMIC DEEP BRAIN STIMULATION FOR PARKINSON DISEASE. WORD NEUROSURG. APR 2010; 73(4):338-344. SUMMARY: THE AUTHORS REPORTED A SINGLE CENTER, RETROSPECTIVE ANALYSIS OF COMPLICATIONS IN A LARGE POPULATION OF PARKINSONIAN PATIENTS WITH A LONG-TERM FOLLOW-UP (MEAN, 4.6 YEARS). A TOTAL OF 141 PATIENTS UNDERWENT BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) BETWEEN NOVEMBER 1998 AND DECEMBER 2007. IN THIS SERIES, NEITHER SEIZURES NOR EXTRADURAL/SUBDURAL HEMATOMAS WERE OBSERVED. REPORTABLE EVENT: ONE PATIENT HAD A MAJOR INFECTION THAT STARTED FROM THE IPG AND RAPIDLY EXTENDED ALONG THE EXTENSION WIRES. PSEUDOMONAS AERUGINOSA WAS ISOLATED FROM THE HARDWARE AND IN THE SURROUNDING TISSUE; BOTH THE IPG AND THE EXTENSION WIRES WERE REMOVED TO ACHIEVE INFECTION HEALING AND TO PREVENT INTRACRANIAL DISSEMINATION OF THE INFECTION. ANTIBIOTIC THERAPY WAS MAINTAINED FOR AT LEAST 3 WEEKS. THIS PATIENT WAS REOPERATED, WITH A SUCCESSFUL REPRISE OF STN DBS. THIS COMPLICATION REQUIRED A LONGER IN-HOSPITAL STAY FOR THE PATIENT; HOWEVER, THE PATIENT DID NOT SHOW SIGNIFICANT COMORBIDITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R EXPLANTED:| LEAD: MODEL #3389, LOT #UNK| IMPLANTED:| PROGRAMMER: MODEL #PROGRAMMER, LOT #UNK| EXTENSION: MODEL #EXTENSION MVD, LOT #UNK| EXPLANTED:| IMPLANTED: