BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2162427 · Received July 14, 2011

    Report

    Report Number
    3006630150-2011-01094
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 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 COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-1110-02, (B)(4), DESCRIPTION: IPG KIT WITHOUT PULL-THROUGH TUNNELER MODEL#:SC-8116-50, (B)(4), DESCRIPTION:SCS PADDLE LEAD - 50CM 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 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'S ENTIRE SYSTEM WAS REPLACED DUE TO INFECTION. THE PATIENT'S INFECTION IS LOCATED AT THE LEAD SITE. THE PATIENT'S SYMPTOMS ARE REDNESS AND SWELLING. THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS. THE PHYSICIAN DOES NOT BELIEVE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S ENTIRE SYSTEM WAS REPLACED DUE TO INFECTION. THE PATIENT'S INFECTION IS LOCATED AT THE LEAD SITE. THE PATIENT'S SYMPTOMS ARE REDNESS AND SWELLING. THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS. THE PHYSICIAN DOES NOT BELIEVE INFECTION IS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8116-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention