BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 6648632 · Received June 16, 2017

    Report

    Report Number
    3006630150-2017-02255
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    May 30, 2017
    Report Date
    May 30, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2208-70 SERIAL: (B)(4) DESCRIPTION: LINEAR ST LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR AN UNKNOWN REASON AND NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427667 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention