BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 1314031 · Received February 16, 2009

    Report

    Report Number
    2182207-2009-01010
    Event Type
    Malfunction
    Date Received
    February 16, 2009
    Date of Event
    November 25, 2008
    Report Date
    January 14, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: BHATIA S, OH M, WHITING T, QUIGLEY M, WHITING D. SURGICAL COMPLICATIONS OF DEEP BRAIN STIMULATION: A LONGITUDINAL SINGLE SURGEON, SINGLE INSTITUTION STUDY. STEREOTACT FUNCT NEUROSURG. 2008; 86(6): 367-372. SUMMARY: THIS REPORT ANALYZED THE COMPLICATIONS OF A SINGLE SURGEON AT ONE INSTITUTION OVER A 10-YEAR PERIOD. A TOTAL OF 191 PATIENTS RECEIVED 330 ELECTRODES IMPLANTS. THERE WERE 59 COMPLICATIONS IN 53 OF THE 191 PATIENTS. PATIENT 9 OF 12 EXPERIENCED A MINOR WOUND RELATED PROBLEM. MINOR WOUND RELATED PROBLEMS DID NOT REQUIRE HARDWARE REMOVAL. PROBLEMS INCLUDED INFECTIONS, HEMATOMAS, SEROMAS, WOUND DEHISCENCE, AND EROSIONS. SEE MANUFACTURER REPORT NUMBER: 2182207200901002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXPLANTED:| EXTENSION: MODEL EXTENSION MVD| LEAD:MODEL LEADMVD| IMPLANTED:| EXPLANTED: