BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3133233 · Received May 29, 2013

    Report

    Report Number
    3006630150-2013-01095
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2012. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-70. SERIAL/LOT #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM; MODEL #: (B)(4), SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING RASHES AND ITCHINESS IN VARIOUS PARTS OF HER BODY. IT IS UNKNOWN IF THE SYMPTOMS WERE DEVICE OR PROCEDURE RELATED. THE PHYSICIAN PRESCRIBED MEDICATION AND REFERRED THE PATIENT TO A DERMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234605 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention