BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1062317 · Received June 18, 2008

    Report

    Report Number
    2029203-2008-00368
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE IPG REVEALED SCRATCHES ON THE CASE. AFTER ONE CHARGE CYCLE, IPG PASSED PHOTOGRAPHIC IMAGE INSPECTION, MECHANICAL AND ONE ELECTRICAL TEST PERFORMED. HIGH IMPEDANCE WAS OBSERVED AT ONE ELECTRODE CONTACT. FURTHER ANALYSIS OF THE IPG COULD NOT BE PERFORMED SINCE THE PATIENT REQUESTED THAT THE PRODUCT BE RETURNED INTACT. VISUAL INSPECTION OF THE LEAD SHOWED THAT IT WAS CUT AND DAMAGED. THE DAMAGED TO THE LEAD IS A TYPICAL RESULT OF AN EXPLANT PROCEDURE. THE PROXIMAL PORTION OF THE LEAD PASSED PHOTOGRAPHIC IMAGE INSPECTION PERFORMED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PT DECIDED TO EXPLANT HER SYSTEM DUE TO INADEQUATE PARESTHESIA AND AN UNCOMFORTABLE FEELING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 SC-8116-70 - EXPLANTED