BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2022829 · Received March 17, 2011

    Report

    Report Number
    3006630150-2011-00361
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # - SC-2138-50 SERIAL #'S - (B)(4). DESCRIPTION - LINEAR LEAD, 50 CM WITH PRE-LOADED 0.012 INCH STYLET.

    Additional Manufacturer Narrative · 1

    DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS BEEN UNABLE TO CHARGE HER IMPLANT IN OVER A YEAR. THE PHYSICIAN ASSESSED THE POCKET SITE AND BELIEVES THAT THE IPG HAS FLIPPED INSIDE THE POCKET. THE POCKET WILL NOT BE REVISED AS THE PATIENT HAS INSTEAD CHOSEN TO HAVE THE ENTIRE SYSTEM EXPLANTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS BEEN UNABLE TO CHARGE HER IMPLANT IN OVER A YEAR. THE PHYSICIAN ASSESSED THE POCKET SITE AND BELIEVES THAT THE IPG HAS FLIPPED INSIDE THE POCKET. THE POCKET WILL NOT BE REVISED AS THE PATIENT HAS INSTEAD CHOSEN TO HAVE THE ENTIRE SYSTEM EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention