BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3213795 · Received July 9, 2013

    Report

    Report Number
    3006630150-2013-01421
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS DOING WELL FOLLOWING THE PROCEDURE. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, 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 IN TWO CYCLES FROM ITS HIBERNATION. HOWEVER, IN THE PROFILE DATA, THE CHARGING DIFFICULTY WAS EVIDENT SIMILAR TO THE CHARACTERISTICS OF TILTED IPG ORIENTATION OR DEEP POCKET. THE REPORTED ELECTRICAL SURGE COULD NOT BE DUPLICATED ON THE TEST BENCH. THE MONITORED STIMULATION FOUND THAT THE OUTPUTS WERE CONSISTENT AND AMPLITUDE/PULSE WIDTHS WERE VERIFIED TO BE CORRECT ON ALL THE ELECTRODES. IT WAS VERIFIED THAT THERE WAS NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG AND PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THE BATTERY WAS SLIGHTLY TILTED DUE TO WEIGHT GAIN. THE PATIENT WILL UNDERGO BATTERY REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG AND PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THE BATTERY WAS SLIGHTLY TILTED DUE TO WEIGHT GAIN. THE PATIENT WILL UNDERGO BATTERY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313980 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 MO Required Intervention