BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4103738 · Received September 19, 2014

    Report

    Report Number
    3006630150-2014-02139
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE : NI.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT WAS RECOVERED/RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S INCISION SITE ALONG THE MIDLINE OF THORACIC SPINE AND IN THE SUPERIOR RIGHT BUTTOCK /FLANK BECAME RED AND SWOLLEN. KEFLEX ANTIBIOTICS WAS PRESCRIBED. THE PATIENT WAS RECOVERING. THE EVENT WAS RELATED TO SURGICAL PROCEDURE AND NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S INCISION SITE ALONG THE MIDLINE OF THORACIC SPINE AND IN THE SUPERIOR RIGHT BUTTOCK /FLANK BECAME RED AND SWOLLEN. KEFLEX ANTIBIOTICS WAS PRESCRIBED. THE PATIENT WAS RECOVERING. THE EVENT WAS RELATED TO SURGICAL PROCEDURE AND NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582634 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention