BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1002331 · Received February 22, 2008

    Report

    Report Number
    2182207-2008-00870
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    November 2, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE OF THE 15 PATIENTS (UNSPECIFIED) HAD SUBSEQUENT HEMI-PARESIS AND FURTHER SECONDARY COMPLICATIONS (PNEUMONIA, PNEUMONIA PLUS EPILEPTIC FITS, PULMONARY EMBOLISM). [SEE SCANNED PAGES].

    Description of Event or Problem · 1

    JOURNAL REFERENCE: VOGES, J.R. HILKER, ET AL. (2007). "THIRTY DAYS COMPLICATION RATE FOLLOWING SURGERY PERFORMED FOR DEEP BRAIN STIMULATION." MOVEMENT DISORDERS 22(10): 1486-1489. THE ARTICLE DESCRIBES A RETROSPECTIVE STUDY OF 1,183 PATIENTS TREATED WITH DEEP BRAIN-STIMULATION FOR A NUMBER OF CONDITIONS. DATA WAS COLLECTED FROM FIVE CENTERS. THE GOAL OF THE STUDY WAS TO EVALUATE SERIOUS ADVERSE EVENTS OCCURING DURING THE FIRST 30 POSTOPERATIVE DAYS. A NUMBER OF PATIENT COMPLICATIONS WERE PRESENTED IN THE ARTICLE. INTRACRANIAL HEMORRHAGES CAUSED NEUROLOGICAL DEFICITS IN 15 PATIENTS (LEADS N=15). SIX PATIENTS EXPERIENCED TRANSIENT SYMPTOMS AND 9 PATIENTS HAD SYMPTOMS THAT PERSISTED BEYOND THE 30 DAY STUDY PERIOD. THREE OF THE 15 PATIENTS (UNSPECIFIED) HAD SUBSEQUENT HEMI-PARESIS AND FURTHER SECONDARY COMPLICATIONS (PNEUMONIA, PNEUMONIA PLUS EPILEPTIC FITS, PULMONARY EMBOLISM). TREATMENT AND OUTCOME INFORMATION WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other SYSTEMS WERE USED IN THE STUDY| UNSPECIFIED