BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 6857046 · Received September 11, 2017

    Report

    Report Number
    3006630150-2017-03443
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    August 21, 2017
    Report Date
    August 23, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NI

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S REMOTE CONTROL DOES NOT COMMUNICATE WITH THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636930 NI SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1