BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2110756 · Received June 1, 2011

    Report

    Report Number
    3006630150-2011-00806
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-1110-02 SERIAL#: (B)(4) DESCRIPTION: IPG KIT WITHOUT PULL-THROUGH TUNNELER MODEL#:SC-2352-50 SERIAL#: (B)(4) DESCRIPTION: LINEAR 3-4 LEAD 50CM MODEL#: SC-3138-35 SERIAL#: (B)(4) DESCRIPTION: SCS PHIII EXT 35CM.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO THE LEAD WOUND NOT HEALING PROPERLY. A CULTURE WAS NOT TAKEN. THE PATIENT IS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO THE LEAD WOUND NOT HEALING PROPERLY. A CULTURE WAS NOT TAKEN. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention