BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2032156 · Received March 28, 2011

    Report

    Report Number
    3006630150-2011-00440
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # - SC-1110-02 SERIAL # - (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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A ROUTINE LEAD REVISION SURGERY DUE TO LEAD MIGRATION, THE PHYSICIAN DISCOVERED A GREY OOZING AT THE LEAD AND IPG SITES AND CHOSE TO EXPLANT THE PATIENT'S ENTIRE SYSTEM. THE PHYSICIAN STATED THAT THE INFECTION IS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A ROUTINE LEAD REVISION SURGERY DUE TO LEAD MIGRATION, THE PHYSICIAN DISCOVERED A GREY OOZING AT THE LEAD AND IPG SITES AND CHOSE TO EXPLANT THE PATIENT'S ENTIRE SYSTEM. THE PHYSICIAN STATED THAT THE INFECTION IS NOT DEVICE RELATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention