BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2304881 · Received October 24, 2011

    Report

    Report Number
    3006630150-2011-01666
    Event Type
    Injury
    Date Received
    October 24, 2011
    Date of Event
    June 14, 2006
    Report Date
    August 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-8116-70 (B)(4) DESCRIPTION: ARTISAN 2X8 PADDLE LEAD, 70 CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S ENTIRE SYSTEM WAS EXPLANTED DUE TO DISCOMFORT AT THE POCKET SITE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention