BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA ®

    MDR report key: 3163627 · Received June 11, 2013

    Report

    Report Number
    3006630150-2013-01192
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING IRRITATION AT THE POCKET SITE. SYMPTOM INCLUDES INFLAMMATION. THE PHYSICIAN BELIEVED THAT THE EVENT WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN ANTIBIOTICS AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263721 PRECISION SPECTRA ® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention