BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2013425 · Received March 10, 2011

    Report

    Report Number
    3006630150-2011-00334
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS TAKING BICEROL ORAL MEDICATION AND ELECTED NOT TO TAKE AN ALLERGY TEST. THE PATIENT HAS ELECTED NOT TO HAVE THE SYSTEM EXPLANTED. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # - SC-2218-50, SERIAL # - (B)(4). DESCRIPTION - ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCHES STYLET.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS BEEN ON MEDICATION FOR HIVES SINCE BEING IMPLANTED. THE PATIENT MENTIONED THAT SHE IS ALLERGIC TO SOME METALS. AN ALLERGY TEST WILL ALSO BE PERFORMED. THE PHYSICIAN PLANS ON EXPLANTING THE PATIENT'S ENTIRE SYSTEM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS BEEN ON MEDICATION FOR HIVES SINCE BEING IMPLANTED. THE PATIENT MENTIONED THAT SHE IS ALLERGIC TO SOME METALS. AN ALLERGY TEST WILL ALSO BE PERFORMED. THE PHYSICIAN PLANS ON EXPLANTING THE PATIENT'S ENTIRE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 206598

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention