BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 6650046 · Received June 19, 2017

    Report

    Report Number
    3006630150-2017-02264
    Event Type
    Injury
    Date Received
    June 19, 2017
    Date of Event
    March 17, 2010
    Report Date
    May 31, 2017
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED DATE: 2010 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8120-70 SERIAL #: (B)(4) , DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    EXPLANTED DATE: 2010. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8120-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN ALLERGIC REACTION WITH THE METAL COMPONENT OF THE DEVICE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN ALLERGIC REACTION WITH THE METAL COMPONENT OF THE DEVICE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430144 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention