BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4963219 · Received August 4, 2015

    Report

    Report Number
    3006630150-2015-01956
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Report Date
    July 15, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF THE IPG WOULD NOT CHARGE OR PROVIDE PARESTHESIA WAS NOT CONFIRMED. THE DEVICE WAS ABLE TO PROVIDE STIMULATION AND EXHIBITED NORMAL CHARGING AND DISCHARGING CHARACTERISTICS. DURING TESTING, IT WAS DETERMINED THAT THE ANALOG INTEGRATED CIRCUIT HAD DAMAGE TO THE CASE CELL DRIVER NODE LOCATED IN THE ANALOG INTEGRATED CIRCUIT. THIS DAMAGE IS A RESULT OF A MAGNETIC RESONANCE IMAGING PROCEDURE THE PATIENT UNDERWENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NO LONGER FUNCTIONING. THE IPG WILL NO LONGER CHARGE AFTER AN MRI PROCEDURE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. DEVICE MALFUNCTION WAS NOT SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS NO LONGER FUNCTIONING. THE IPG WILL NO LONGER CHARGE AFTER AN MRI PROCEDURE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. DEVICE MALFUNCTION WAS NOT SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508179 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1