BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2250705 · Received September 12, 2011

    Report

    Report Number
    3007566237-2011-07740
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    November 6, 2010
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): (PNEUMOCEPHALUS; HYPODENSE AREA). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: DEOGAONKAR M, NAZZARO JULES M, MACHADO A, REZAI A. TRANSIENT SYMPTOMATIC, POST-OPERATIVE, NON-INFECTIOUS HYPODENSITY AROUND THE DEEP BRAIN STIMULATION (DBS) ELECTRODE. J CLIN NEUROSCI. 2011:18(7);910-915. DOI: 10.1016/J.JOCN.2010.11.020. SUMMARY: THE AUTHORS DISCUSS MORPHOLOGICAL CHARACTERISTICS OF POST-OPERATIVE EDEMA AROUND A DBS LEAD IN PTS WHO PRESENTED BETWEEN 2004 AND 2009. REPORTABLE EVENT: ONE (B)(6) FEMALE PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF WORSENING SYMPTOMS 9 DAYS FOLLOWING GPI DBS IMPLANTATION. EDEMA WAS FOUND AT THE TIP OF THE LEAD. NO INTERVENTION WAS CARRIED OUT AND THE EDEMA RESOLVED IN 30 DAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNK| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNK