BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 6141924 · Received December 2, 2016

    Report

    Report Number
    3004209178-2016-25052
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    January 1, 2015
    Report Date
    March 6, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-28, LOT# L78028, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY HAD THEIR DEVICE ADJUSTED BY A MANUFACTURING REPRESENTATIVE LAST YEAR, AND SINCE THEN, THEIR STIMULATION HAS BEEN TOO FAST AND TOO HIGH. THE PATIENT NOTED THAT THIS WOULD CAUSE THEM TO LOSE BALANCE AND FALL. THEY STATED THAT THE STIMULATION WOULD EITHER ¿JERK THEM TOO FAST¿, OR WOULD NOT BE STRONG ENOUGH AT ALL. THE PATIENT MENTIONED THAT THIS HAS OCCURRED A COUPLE OF TIMES SINCE 2015, BUT THE MOST RECENT OCCURRENCE IN 2016 WAS THE WORST. THEY FURTHER EXPLAINED THAT THEY STOOD UP TALLER THAN NORMAL, AND THEN EXPERIENCED OVERSTIMULATION SO BAD THAT THEIR LEGS WENT OUT FROM UNDER THEM AND THEY WERE THROWN TO THE FLOOR. THE PATIENT STATED THAT THEIR COMPLEX REGIONAL PAIN SYNDROME SPREADS, AND THEY ARE UNSURE IF IT IS CAUSING THEIR LOWER BACK PAIN. THE PATIENT INDICATED THAT THEY HAVE LOWER BACK PAIN WHERE THEIR WIRE GOES ACROSS THEIR BODY TO THE BATTERY IN THEIR BUTT CHEEK. THEY NOTED THAT THERE IS A LUMP BY THE WIRE THAT HURTS, AND HAS WORSENED OVER THE YEARS; THEY ARE UNSURE WHEN THIS STARTED. THE PATIENT ALSO MENTIONED THAT THEY FELL AND BROKE THEIR WRIST IN 2011, BUT THEY AREN¿T SURE IF IT HAD AN EFFECT ON THEIR DEVICE. THE PATIENT WAS TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER. THE PATIENT WAS IMPLANTED FOR COMPLEX REGIONAL PAIN SYNDROME TYPE I

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED WHEN THEY TRIED TURNING STIMULATION UP IT JOLTED THEM AND GAVE THEM SUCH HIGH STIMULATION AT ONCE IT THREW THEM TO THE FLOOR FROM THEIR LEG GOING NUMB. THE CONSUMER FURTHER REPORTED THEIR BATTERY WAS REPLACED ON (B)(6) 2017 BECAUSE THE ¿BATTERY WAS JUST ABOUT DEAD,¿ IT WAS BARELY WORKING, AND THERE WAS NO STIMULATION. IT WAS NOTED THE MANUFACTURER¿S REPRESENTATIVE (REP) CHECKED THE DEVICE ON (B)(6) 2016 AND IT WAS STILL WORKING, BUT BARELY, AND THAT¿S WHY THEY DIDN¿T FEEL STIMULATION AND WERE SCHEDULED FOR A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792694 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention