BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2914555 · Received January 14, 2013

    Report

    Report Number
    3006630150-2013-00039
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-1110-02 (SERIAL # (B)(4)) - DEVICE EVALUATION INDICATED THAT THE IPG PASSED OPERATIONAL, PERFORMANCE, ELECTRICAL, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF GETTING BURNING SENSATION COULD NOT BE VERIFIED. THE CHARGE PROFILE INDICATES THAT THE MAXIMUM TEMPERATURE DURING CHARGING CYCLES IN THE PATIENT'S BODY WAS 40.37 °C, WITHIN THE EXPECTED RANGE. THE TEMPERATURE OF THE DEVICE WAS MONITORED WHILE THE DEVICE WAS TURNED ON AND OFF RANDOMLY. THE WORKING TEMPERATURE OF THE DEVICE FOR TWO-HOUR OBSERVATION RANGES ALONG AROUND 24 °C, AND NO SURGE IN TEMPERATURE WAS OBSERVED. AC/DC CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED THAT THERE WAS NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. THE DEVICE PASSED ALL REQUIRED TESTS. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. SC-2218-50 (SERIAL # (B)(4)) - DEVICE EVALUATION INDICATED THAT THE LEADS PASSED PHOTOGRAPHIC IMAGING TESTS PERFORMED. SC-4316 (SERIAL #(B)(4)) - NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-4316 SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION AND DISCOMFORT WHEN THE STIMULATOR WAS ON. REPROGRAMMING WAS ATTEMPTED BUT UNSUCCESSFUL. EXPLANT PROCEDURE WAS DONE WHEREIN THE IPG WAS REPLACED WITH A NEW ONE AND THE PERCUTANEOUS LEADS WERE REPLACED WITH PADDLE LEADS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION AND DISCOMFORT AT THE BATTERY SITE. THE PATIENT ALSO COMPLAINED THAT THE CLIK ANCHORS WERE SUPERFICIAL CAUSING IRRITATION. REPROGRAMMING WAS ATTEMPTED BUT UNSUCCESSFUL. DATABASE ANALYSIS REVEALED NO ANOMALIES. EXPLANT PROCEDURE WAS DONE WHEREIN THE IPG, LEADS AND CLIK ANCHOR WERE REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION AND DISCOMFORT WHEN THE STIMULATOR WAS ON. REPROGRAMMING WAS ATTEMPTED BUT UNSUCCESSFUL. EXPLANT PROCEDURE WAS DONE WHEREIN THE IPG WAS REPLACED WITH A NEW ONE AND THE PERCUTANEOUS LEADS WERE REPLACED WITH PADDLE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21050 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention