BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2010396 · Received March 8, 2011

    Report

    Report Number
    3006630150-2011-00317
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LOCATION OF THE INFECTION WAS ON THE RIGHT SIDE TOWARDS THE IPG POCKET. THE PATIENT'S SYMPTOMS INCLUDED REDNESS, TENDERNESS AND FEVER. THE PATIENT WAS GIVEN IV ANTIBIOTICS AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2138-50 SERIAL # (B)(4), (B)(4) DESCRIPTION: LINEAR LEAD, 50 CM WITH PRE-LOADED 0.012 INCH STYLET MODEL # SC-3138-35 SERIAL # (B)(4), (B)(4) DESCRIPTION: LEAD EXTENSION, 35CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG, LEADS, AND LEAD EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG, LEADS, AND LEAD EXTENSIONS FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION WAS EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION WAS EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION WAS EXPLANTED DUE TO INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention