BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1961040 · Received January 11, 2011

    Report

    Report Number
    3006630150-2011-00031
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    November 19, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IMPLANTED DEVICE 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 THE PATIENT HAS SWELLING AT THE IPG SITE. THE SWELLING HAD DECREASED SINCE BEING IMPLANTED BUT WAS STILL PRESENT. THE PATIENT WAS STARTED ON IV ANTIBIOTICS FOR 6 WEEKS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THE PATIENT HAS SWELLING AT THE IPG SITE. THE SWELLING HAD DECREASED SINCE BEING IMPLANTED BUT WAS STILL PRESENT. THE PATIENT WAS STARTED ON IV ANTIBIOTICS FOR 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention