BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1221246 · Received November 5, 2008

    Report

    Report Number
    2029203-2008-00831
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP.
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    GOOD FAITH EFFORT WAS MADE TO CONTACT THE PT WITHOUT SUCCESS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT OF AN UNCOMFORTABLE IMPLANT WAS REC'D. THE PT HAS LOST WEIGHT AND NOW THE IMPLANT IS PUSHING AGAINST HIS SKIN. THE PT WILL BE DISCUSSING WITH HIS PHYSICIAN TO HAVE A POCKET REVISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention