BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2250706 · Received September 12, 2011

    Report

    Report Number
    3007566237-2011-07723
    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) LEFT-HANDED MALE WITH A HISTORY OF IDIOPATHIC PARKINSON'S DISEASE (PD) WAS ADMITTED FOR PLACEMENT OF A RIGHT-SIDED STN ELECTRODE. IMMEDIATE POST-OPERATIVE CT HEAD SCANS REVEALED MINIMAL PNEUMOCEPHALUS WITH NO PARENCHYMAL HEMORRHAGE. THE PT WAS DISCHARGED ON POSTOPERATIVE DAY 2 WITH A NORMAL EXAM. HIS SECOND STAGE OF SURGERY FOR IMPLANTATION OF THE IPG WAS SCHEDULED FOR A LATER DATE. TWO WEEKS AFTER DISCHARGE, THE PT PRESENTED TO THE EMERGENCY ROOM WITH A HISTORY OF A SINGLE GENERALIZED CONVULSION FOLLOWED BY A BRIEF LOSS OF CONSCIOUSNESS. ON EXAM HE WAS ORIENTATED AND HAD NO FOCAL DEFICITS. A CT BRAIN SCAN REVEALED A LARGE HYPODENSE AREA (3CMX4CMX3CM) CENTERED AROUND THE LEFT DBS ELECTRODE PRIMARILY IN THE SUBCORTICAL REGION AND CENTRUM SEMIOVALE THAT DID NOT ENHANCE ON CONTRAST ADMINISTRATION. NO LOCAL OR SYSTEMIC SIGNS OR SYMPTOMS OF INFECTION WERE PRESENT. HE DID NOT HAVE ANY FURTHER EPISODES OF SEIZURE AND WAS DISCHARGED HOME ON ANTI-CONVULSANT MEDICATION AND A SHORT COURSE OF ORAL STEROIDS. A F/U CT SCAN AFTER 1 WEEK SHOWED RESOLUTION OF THE EDEMA. THE PT WAS NOT GIVEN ANTIBIOTICS. SEE LITERATURE ARTICLE WITH MFR REPORT # 3007566237201107706.

    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 69 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# UNK