BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2011169 · Received March 8, 2011

    Report

    Report Number
    3006630150-2011-00320
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-1110-02, (B)(4). DESCRIPTION: IPG KIT (WITHOUT PULL-THROUGH TUNNELER). 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 DURING A LEAD REVISION DUE TO LEAD MIGRATION, THE PHYSICIAN WAS UNABLE TO REPOSITION THE LEAD AND ELECTED TO EXPLANT THE ENTIRE PRECISION SYSTEM. DURING THE EXPLANT, THE PHYSICIAN TORE THE DURA. A SEALANT WAS USED ON THE DURA AND THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention