BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1895268 · Received November 8, 2010

    Report

    Report Number
    3007566237-2010-09057
    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 (B)(6) 1998 AND (B)(6) 2007. IN THIS SERIES, NEITHER SEIZURES NOR EXTRADURAL/SUBDURAL HEMATOMAS WERE OBSERVED. REPORTABLE EVENT: ONE PATIENT PRESENTED WITH A MINOR INFECTION DUE TO (B)(6); THE INFECTION WAS SUPERFICIAL, AT THE LEVEL OF THE IPG IMPLANTATION, AND RESOLVED AFTER PROLONGED ANTIBIOTIC THERAPY. REMOVAL OF THE DEVICE WAS NOT NECESSARY. THIS COMPLICATION REQUIRED A LONGER IN-HOSPITAL STAY FOR THE PATIENT; HOWEVER, THE PATIENT DID NOT SHOW SIGNIFICANT COMORBIDITY. SEE LITERATURE ARTICLE WITH MFR REPORT #3007566237-2010-08991.

    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 48 YR Hospitalization| R PROGRAMMER: MODEL #PROGRAMMER, LOT #UNK| LEAD: MODEL #3389, LOT #UNK| EXPLANTED:| IMPLANTED:| IMPLANTED: