BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4122616 · Received September 26, 2014

    Report

    Report Number
    3006630150-2014-02203
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2352-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED SPINAL HEADACHE, WHICH WAS TREATED WITH A MEDICATION. THE EVENT WAS RESOLVED AND WAS KNOWN TO BE RELATED TO THE PROCEDURE AND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601072 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention