BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3120854 · Received May 20, 2013

    Report

    Report Number
    3006630150-2013-00993
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM, MODEL #: SC-4316 SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOES NOT BELIEVE THE ITCHINESS WAS DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING ITCHING WHETHER THE STIMULATION WAS ON OR OFF. THE PHYSICIAN PRESCRIBED THE PATIENT WITH ANTIHISTAMINE. IT WAS UNKNOWN IF ITCHING WAS DEVICE RELATED. THE PATIENT WAS DOING WELL AND THE ITCHING HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING ITCHING WHETHER THE STIMULATION WAS ON OR OFF. THE PHYSICIAN PRESCRIBED THE PATIENT WITH ANTIHISTAMINE. IT WAS UNKNOWN IF ITCHING WAS DEVICE RELATED. THE PATIENT WAS DOING WELL AND THE ITCHING HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221671 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention