BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3182723 · Received June 21, 2013

    Report

    Report Number
    3006630150-2013-01307
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS BECOMING HOT DURING CHARGING. THE PATIENT TURNED THE IPG OFF FOR A COUPLE WEEKS BUT STARTED TO FEEL OVERSTIMULATION WHICH CAUSED THE PATIENT TO LOSE CONSCIOUSNESS. THE PATIENT REPORTED THAT AFTER THE DEVICE WAS IMPLANTED SHE WAS EXPERIENCING INCREASED HEADACHES, PAIN AND DEPRESSION WHICH SHE HAD BEEN TAKING MEDICATION FOR. THE PATIENT MET WITH A PHYSICIAN AND AN X RAY WAS PERFORMED, WHICH SHOWED THE IPG HAD FLIPPED UPSIDE DOWN. THE PHYSICIAN SUGGESTED THAT THE PATIENT HAS THE IPG REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282770 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention