BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 9131075 · Received September 27, 2019

    Report

    Report Number
    3006630150-2019-05383
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    September 8, 2019
    Report Date
    October 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED VIA SOCIAL MEDIA THAT THE PATIENTS SCS SYSTEM MADE THE PATIENT WORSE AND HAD IT EXPLANTED.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED VIA SOCIAL MEDIA THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND WAS PRESCRIBED WITH PAIN MEDICATIONS. NO FURTHER INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED VIA SOCIAL MEDIA THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND WAS PRESCRIBED WITH PAIN MEDICATIONS. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922724 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention