BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1895251 · Received November 8, 2010

    Report

    Report Number
    3007566237-2010-09020
    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 EXPERIENCED AN INFECTION OF THE INTRACRANIAL LEAD: THE CONTROL MRI SHOWED A SIGNAL CHANGE IN BOTH T1 AND T2 SEQUENCES ALONG THE LEAD. CULTURES WERE NEGATIVE; THE PATIENT UNDERWENT THE REMOVAL OF THE INFECTED ELECTRODE AND WAS STARTED ON AN ANTIBIOTIC THERAPY. THE PT WAS SUCCESSFULLY REIMPLANTED 6 MONTHS LATER AFTER RESOLUTION OF THE INFECTION. 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 61 YR Hospitalization| R PROGRAMMER: MODEL PROGRAMMER, LOT #UNK| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389, LOT #UNK| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT #UNK