BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3217466 · Received July 10, 2013

    Report

    Report Number
    3006630150-2013-01427
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL/LOT #:(B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50 CM. MODEL #: SC-3138-25, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS PHIII EXT 25CM. MODEL #: SC-3400-30, SERIAL/LOT #: (B)(4), DESCRIPTION: INFINION SPLITTER 2X8 KIT (30 CM).

    Additional Manufacturer Narrative · 1

    IPG ((B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT ABOUT THE DIFFICULTY CHARGING IPG WAS NOT VERIFIED. IN THE LAB, THERE WAS NO ISSUE COUPLING THE IPG WITH A CHARGER, AND THE IPG WAS CHARGED 4.06 VOLTS IN TWO CYCLES FROM ITS HIBERNATION. THE REPORTED ELECTRICAL SURGE COULD NOT BE DUPLICATED ON THE TEST BENCH. SINCE THE RETURNED LEADS EXPOSED SUBSTANTIAL DAMAGES, THE IPG WAS INVESTIGATED WITH KNOWN GOOD LEADS. THE MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THAT THE OUTPUTS WERE CONSISTENT AND AMPLITUDE/PULSE WIDTHS WERE VERIFIED TO BE CORRECT ON ALL THE UNBROKEN ELECTRODES. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED THAT THERE IS NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. LEAD ((B)(4)) THE LEAD WAS CUT, AND ONLY THE PROXIMAL END WAS RETURNED. THE DAMAGE WAS CONSIDERED AS EXPLANT DAMAGE, AND WAS NOT CONSIDERED A FAILURE. SPLITTER ((B)(4)) VISUAL AND X-RAY INSPECTIONS WERE PERFORMED TO ENSURE THE DEVICE INTEGRITY. NO ANOMALIES WERE FOUND. THE EXPLANTED LEAD EXTENSIONS SC-3138-25 ((B)(4)) WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. LEAD EXTENSIONS ((B)(4)) A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A SURGE AND THE BATTERY WOULD NOT ACCEPT A CHARGE ANYMORE. THE PATIENT UNDERWENT AN EXPLANT OF THE WHOLE SYSTEM AND WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A SURGE AND THE BATTERY WOULD NOT ACCEPT A CHARGE ANYMORE. THE PATIENT UNDERWENT AN EXPLANT OF THE WHOLE SYSTEM AND WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314775 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR