BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 6186455 · Received December 19, 2016

    Report

    Report Number
    3006630150-2016-03725
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NI.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AS PER SOCIAL MEDIA TRIAL ALMOST KILLED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836691 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention