BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2130787 · Received June 16, 2011

    Report

    Report Number
    3006630150-2011-00922
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT HAD A PERVASIVE INFECTION. THE PHYSICIAN BELIEVES THE INFECTION WAS CAUSED BY THE PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2138-70 (B)(4), DESCRIPTION: LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012 INCHES STYLET THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, DUE TO LEAD MIGRATION, THE PHYSICIAN CHOSE TO EXPLANT THE PATIENT'S PRECISION SYSTEM DUE TO AN INFECTION. THE PATIENT WAS PLACED ON CIPROFLOXACIN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A LEAD REVISION PROCEDURE, DUE TO LEAD MIGRATION, THE PHYSICIAN CHOSE TO EXPLANT THE PATIENT'S PRECISION SYSTEM DUE TO AN INFECTION. THE PATIENT WAS PLACED ON CIPROFLOXACIN.

    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 55 YR Required Intervention