BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1895249 · Received November 8, 2010

    Report

    Report Number
    3007566237-2010-09043
    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

    LITERATURE: VERGANI F, LANDI A, PIRILLO D, CILIA R, ANTONINI A, SGANZERLA EP. SURGICAL, MEDICAL, AND HARDWARE ADVERSE EVENTS IN A SERIES OF 141 PATIENTS UNDERGOING SUBTHALAMIC DEEP BRAIN STIMULATION FOR PARKINSON DISEASE. WORLD 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. CULTURES WERE NEGATIVE HOWEVER, BOTH THE IPG AND 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 NOT REOPERATED BECAUSE OF A POOR RESPONSE ON THAT SIDE TO THE STNDBS. 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 69 YR Hospitalization| R LEAD: MODEL #3389, LOT #UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL #PROGRAMMER, LOT #UNK| EXTENSION: MODEL #EXTENSION MVD, LOT #UNK| IMPLANTED: