BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2132679 · Received June 17, 2011

    Report

    Report Number
    3006630150-2011-00910
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2218-70 (B)(4) MODEL DESCRIPTION:ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014 INCH STYLET MODEL#:SC-3138-25 (B)(4) MODEL DESCRIPTION:LEAD EXTENSION, 25CM 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 THE PATIENT WAS EXPLANTED DUE TO INFECTION. THE SYMPTOMS OF INFECTION WERE PAIN AT THE INCISION SITE AND THE BLOOD WAS SEEPING OUT AS WELL. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. THE SYMPTOMS OF INFECTION WERE PAIN AT THE INCISION SITE AND THE BLOOD WAS SEEPING OUT AS WELL. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention