BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1081243 · Received July 24, 2008

    Report

    Report Number
    2029203-2008-00473
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    February 1, 2008
    Report Date
    June 2, 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

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED REGARDING THE PT EXPERIENCING A BURNING SENSATION AND BLISTERS AT THE IMPLANT SITE WHILE SYSTEM WAS ON OR OFF. THE DECISION HAS BEEN MADE TO EXPLANT THE PATIENT'S SYSTEM.

    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 Required Intervention