BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 6932325 · Received October 9, 2017

    Report

    Report Number
    3006630150-2017-04074
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    May 17, 2016
    Report Date
    September 9, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2138-50 SERIAL #: (B)(4) DESCRIPTION: SCS 50CM III LEAD MODEL#: SC-8116-70 SERIAL #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING ANXIETY AND HUNGER WHEN STIMULATION WAS ON. IT WAS ALSO NOTED THAT THE STIMULATION WAS AFFECTING THE PATIENTS NERVOUS SYSTEM. THE PATIENT WAS ADMITTED TO THE PSYCHIATRIC UNIT AND RESTARTED ON ANTI-ANXIETY MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709299 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R