BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2172309 · Received July 22, 2011

    Report

    Report Number
    3006630150-2011-01128
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT HAS BEEN CONFIRMED. THE IPG HAS ATE (AUTOMATED TEST EQUIPMENT) STIMULATION PARAMETERS THAT WERE NOT CLEARED PRIOR THE IMPLANT PROCEDURE AND IT RESULTED IN THE REPORTED PATIENT OVERSTIMULATION. THE FOLLOWING OBSERVATIONS WERE DUPLICATED IN THE LAB: THE ASSOCIATED REMOTE CONTROL(RC) WAS LINKED WITH THE IPG AND IT DISPLAYED THAT THE STIMULATION AMPLITUDE WAS SET TO MAXIMUM. THE RC ALSO SHOWED THAT THERE IS ONE PROGRAM SAVED IN THE IPG. THE STIMULATION AMPLITUDE DIDN'T DECREASE AND THE RC ONLY BEEPS WHEN THE ARROW DOWN BUTTON ON THE RC WAS PRESSED. BIONIC NAVIGATOR DISPLAYED THE ERROR MESSAGE INCORRECT SETTINGS DETECTED IN SOME OR ALL OF THE AREAS. THESE AREAS WILL BE CLEARED. RESEARCH AND DEVELOPMENT DEPARTMENT CONFIRMED THAT THE IPG WAS ACCIDENTALLY PROGRAMMED WITH ATE STIMULATION PARAMETERS DURING MANUFACTURING. THE ATE SOFTWARE WAS UTILIZED TO READ THE ELECTRODE AND TIMING SETTINGS OF THE IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT UPON THE FIRST USE OF THE IPG THE PATIENT RECEIVED A SHOCK THAT LASTED FOR TEN MINUTES. THE BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE DEVICE AND FOUND THAT THE IPG PROGRAM WAS SET AT THE HIGHEST SETTING. THE PHYSICIAN CHOSE EXPLANT THE PATIENT'S IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT UPON THE FIRST USE OF THE IPG THE PATIENT RECEIVED A SHOCK THAT LASTED FOR TEN MINUTES. THE BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE DEVICE AND FOUND THAT THE IPG PROGRAM WAS SET AT THE HIGHEST SETTING. THE PHYSICIAN CHOSE EXPLANT THE PATIENT'S IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention