BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 11911725 · Received June 1, 2021

    Report

    Report Number
    3006630150-2021-02545
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 7, 2019
    Report Date
    July 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EHE PATIENT WAS EXPERIENCING PAIN ON THE RIGHT SHOULDER. THE PATIENT WAS PRESCRIBED ORAL OPIOID MEDICATIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS PAIN IN THE RIGHT SHOULDER WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HE PATIENT WAS EXPERIENCING PAIN ON THE RIGHT SHOULDER. THE PATIENT WAS PRESCRIBED WITH ORAL OPIOID MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811191 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 18984978 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention