BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1241178 · Received November 20, 2008

    Report

    Report Number
    2029203-2008-00978
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED MATERIAL WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A COMPLAINT OF DIFFICULTY CHARGING WAS REC'D. THE PT UNDERWENT A POCKET REVISION DUE TO THE BATTERY BEING TOO DEEP. THE SURGEON DECIDED TO MOVE THE POCKET AND REPLACE THE BATTERY. THE PT IS REPORTEDLY DOING WELL.

    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