BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1150416 · Received September 5, 2008

    Report

    Report Number
    2029203-2008-00585
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WILL NOT BE EVALUATED AS IT WAS DISCARDED BY MEDICAL FACILITY. A REVIEW OF THE STERILIZATION RECORDS FOR THE EXPLANTED DEVICE FOUND THEM TO BE SATISFACTORY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED REGARDING INFECTION AT THE IMPLANT SITE. THE PATIENT'S INCISION SITE CAME OPEN AFTER SUFFERING A FALL. THE SURGEON EXPLANTED PRECISION SYSTEM AND TREATED THE PATIENT WITH ANTIBIOTICS. THE PATIENT IS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ST LINEAR LEAD