BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR

    MDR report key: 1186131 · Received October 3, 2008

    Report

    Report Number
    2182207-2008-06284
    Event Type
    Injury
    Date Received
    October 3, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: BANUELOS PA, TEMES R, LEE VH. NEUROGENIC STUNNED MYOCARDIUM ASSOCIATED WITH REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME. NEUROCRIT CARE. 2008;9(1):108-111. WE REPORT A CASE OF NEUROGENIC-STUNNED MYOCARDIUM AND REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME (RPLS) OCCURRING SIMULTANEOUSLY IN A PATIENT. THE TWO REVERSIBLE CLINICAL SYNDROMES THAT ARE HYPOTHESIZED TO BE A RESULT OF SYMPATHETIC DYSREGULATION. REPORTABLE EVENT: WE PRESENT A WOMAN WITH A HISTORY OF HYPERTENSION AND CHRONIC BACK PAIN STATUS POST SPINAL CORD STIMULATOR, WHO PRESENTED WITH SEVERE HEADACHE, SEIZURE, AND CONFUSION ASSOCIATED WITH ACUTE HYPERTENSION. MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN REVEALED BILATERAL PATCHY T2 SIGNAL HYPERINTENSITY, CONSISTENT WITH RPLS. TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED REGIONAL-WALL MOTION ABNORMALITIES IN THE APICAL REGIONS, CONSISTENT WITH NEUROGENIC-STUNNED MYOCARDIUM. THE PATIENT'S TTE SHOWED NORMALIZATION AT 3 DAYS, WITH MENTAL STATUS RETURNING TO NORMAL BY DAY 5. MRI ABNORMALITIES WERE RESOLVED COMPLETELY AT 1 MONTH FOLLOW-UP STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULATOR LGW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=1| LEAD MODEL UNK N=1