BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2193440 · Received August 5, 2011

    Report

    Report Number
    3006630150-2011-01226
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IPG FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE IPG FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT UNDERWENT A POCKET REVISION DUE TO PAIN AND DISCOMFORT AT THE IPG SITE, AS THE IPG WAS LOCATED NEAR THE SURFACE OF THE SKIN. THE PATIENT'S SYMPTOMS WERE IRRITATION, REDNESS AND HOT AT THE IPG LOCATION. THE PATIENT WAS INVOLVED IN A CAR ACCIDENT (NOT DEVICE RELATED) AND SINCE THE ACCIDENT; THE PATIENT HAS BEEN EXPERIENCING THESE SYMPTOMS. THE PHYSICIAN PRESCRIBED A LIDODERM PATCH AND INJECTIONS FOR THE PAIN. UPON FOLLOW UP, THE PHYSICIAN CHOSE TO REVISE THE IPG LOCATION TO A MORE COMFORTABLE LOCATION. NOTHING WAS IMPLANTED OR EXPLANTED AND THE PATIENT IS REPORTEDLY DOING WELL.

    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 55 YR Required Intervention