BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2034039 · Received March 30, 2011

    Report

    Report Number
    3006630150-2011-00447
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # - SC-2218-50 (B)(4) DESCRIPTION - ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PASSED AWAY FROM DOUBLE PNEUMONIA. THE PHYSICIAN CONFIRMED THE PATIENT'S DEATH WAS NOT DEVICE RELATED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG AND LEADS FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH DOUBLE PNEUMONIA AND A STAPHYLOCOCCUS INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH DOUBLE PNEUMONIA AND A (B)(6). NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 Hospitalization