BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2834185 · Received November 15, 2012

    Report

    Report Number
    3006630150-2012-02094
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8216-70, SERIAL: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM; MODEL: SC-4316, LOT #: 15121770, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. EXPLANTED DEVICES WILL NOT BE RETURNED TO BSN AS IT WAS DISCARDED BY MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO SORENESS AT THE LEAD AND POCKET SITES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention