BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4191441 · Received October 22, 2014

    Report

    Report Number
    3006630150-2014-02401
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A RECENTLY IMPLANTED PATIENT HAD A BRUISE OVER THE IMPLANT. THE PHYSICIAN BELIEVED THAT IT WAS PROCEDURE RELATED AND ADMINISTERED A PAIN PATCH. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672930 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1032B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention