BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4222161 · Received November 3, 2014

    Report

    Report Number
    3006630150-2014-02561
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT WHEN THE BATTERY WAS FULLY DISCHARGED, THE PATIENT HAD NO BURNING OR DISCOMFORT IN THE AREA. IT WAS BELIEVED THAT THE DEVICE MIGHT BE DEFECTIVE. IT WAS ALSO REPORTED THAT THE PATIENT HAD DISCOMFORT IN THE RIGHT FLANK WHEN LEANING BACK AND WAS BELIEVED THAT THE IPG WAS POSITIONED TOO SUPERFICIALLY. THE PATIENT WILL UNDERGO A REPLACEMENT AND RELOCATION OF THE IPG.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND DID WELL POSTOPERATIVELY. DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL, ELECTRICAL, AND PERFORMANCE TESTS PERFORMED. THE SOURCE OF THE COMPLAINT COULD NOT BE DETERMINED. THE PATIENT'S DATA SHOWED THAT THE MAXIMUM TEMPERATURE DURING CHARGING CYCLES WAS 40.71 °C. CURRENT LEAKAGE TESTS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. RESIDUAL GAS ANALYSIS VERIFIED THAT THE DEVICE INSULATION WAS NOT COMPROMISED. THE MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THE OUTPUTS WERE CONSISTENT AND CORRECT ON ALL ELECTRODES. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE UP THE IPG DUE TO THE PAIN AND BURNING SENSATION CAUSED BY THE IPG GETTING TOO HOT WHEN CHARGED. THE PHYSICIAN RECOMMENDED IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE UP THE IPG DUE TO THE PAIN AND BURNING SENSATION CAUSED BY THE IPG GETTING TOO HOT WHEN CHARGED. THE PHYSICIAN RECOMMENDED IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE UP THE IPG DUE TO THE PAIN AND BURNING SENSATION CAUSED BY THE IPG GETTING TOO HOT WHEN CHARGED. THE PHYSICIAN RECOMMENDED IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS UNABLE TO CHARGE UP THE IPG DUE TO THE PAIN AND BURNING SENSATION CAUSED BY THE IPG GETTING TOO HOT WHEN CHARGED. THE PHYSICIAN RECOMMENDED IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702140 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention