BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1833439 · Received September 9, 2010

    Report

    Report Number
    3006630150-2010-01570
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO POCKET AND LEAD REVISIONS DUE TO LACK OF STIMULATION IN THE DESIRED AREAS, CHARGING ISSUES, AND POCKET DISCOMFORT. A BSN FIELD CLINICAL ENGINEER (FCE) REPORTED THAT THE LEAD IS DISPLAYING SEVERAL CONTACTS WITH HIGH IMPEDANCES. THE BSN FCE RECOMMENDED THAT THE PADDLE LEAD BE TESTED INTRAOPERATIVELY DURING THE REVISION. IT WAS ALSO REPORTED THAT THE CHARGING DIFFICULTIES STEMMED FROM THE IPG BEING TILTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 50 CM| MODEL#: SC-8216-50| SERIAL#: (B)(4)| MODEL DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (LIM)