BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1111738 · Received August 12, 2008

    Report

    Report Number
    2029203-2008-00522
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 7, 2007
    Report Date
    July 7, 2007
    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
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED OF A SUSPECTED INFECTION ON THE LEAD EXTENSION SITE. THE DOCTOR ABORTED THE PT'S TRIAL. ALSO REFER TO MDR NO. 2029203-2008-00557.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-3138-35 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention