BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1062103 · Received June 18, 2008

    Report

    Report Number
    2029203-2008-00418
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM REMAINS IMPLANTED IN THE PT AND WILL NOT BE RETURNED FOR EVAL. THE PT IS REPORTEDLY DOING WELL. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    SHORTLY AFTER IMPLANT PROCEDURE, THE PT REPORTED ITCHING AND HIVES. THE PHYSICIAN TREATED THE PT WITH A BENADRYL AND MEDROL DOSE PAK, AND REFERRED THE PT TO AN ALLERGY SPECIALIST. THE ALLERGY SPECIALIST DISCOVERED THAT THE PT WAS HAVING AN ALLERGIC REACTION TO VICODIN, PRESCRIBED FOR POST OPERATIVE PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SC-2008-50| SC-2208-50