BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 4

    MDR report key: 6936741 · Received October 10, 2017

    Report

    Report Number
    3004209178-2017-21502
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    October 5, 2017
    Report Date
    November 6, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169107793
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THE CAUSE OF THE FLUCTUATING IMPEDANCES AND STIMULATION AT THE POCKET WAS UNKNOWN. THE HCP MENTIONED THE LEAD WAS 7-10 YEARS OLD. THE PATIENT WAS REPROGRAMMED AND EDUCATED.THE ISSUES WERE REPORTED AS BEING RESOLVED. THE PATIENT'S WEIGHT WAS PROVIDED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THE PATIENT WOKE UP IN PAIN LAST NIGHT AND THEY WERE NOT GETTING GOOD THERAPY. THE REP CHECKED IMPEDANCES AND REPORTED AT 0.7V IMPEDANCES WERE: C0 2747 C1 885 C2 1861 C3 1669 01 2602 01 818 02 1832 03 1669 C2 818 02 1837 12 1440 23 1669 C3 1669 13 1669 23 1519 AT 3V, IMPEDANCES WERE: C0 2626 C1 921 1980 1881. THE REP MET WITH THE PATIENT ON (B)(6) 2017 FOR A NORMAL APPOINTMENT AND THE STIMULATION WAS WORKING IN THE OFFICE. THE PATIENT WAS PROGRAMMED TO 0- 1+ 2+ YESTERDAY. THE CALLER STATED THE BATTERY WAS REPLACED IN (B)(6) 2017 AND THEY WERE GETTING GOOD THERAPY AT THAT TIME. WHEN THE PATIENT WAS PROGRAMMED C+ 1- THEY FELT STIMULATION IN THE POCKET LOCATION AND TINGLING IN THE LEGS, BUT DID NOT IN THE BACK AT 9.9V. WITH C+ 0- AGAIN THE PATIENT WAS FEELING STIMULATION IN HIGH AMPLITUDES, BUT NOT IN THEIR BACK. THE 01 PAIR WAS PROGRAMMED AND THE PATIENT WAS FEELING STIMULATION IN THEIR LEGS. THE REP THEN ACTIVATED ALL ELECTRODES +++-, SET TO 450US AND 130HZ, AND TURNED UP TO 7V. THE PATIENT STILL WAS NOT FEELING STIMULATION IN THEIR BACK. THE CALLER STATED THAT THE PATIENT NORMALLY RUNS THE AMPLITUDE AROUND 7 VOLTS. IT WAS REVIEWED THAT THE IMPEDANCES WERE SIGNIFICANTLY DIFFERENT FROM THE REPLACEMENT TO NOW. IT WAS ALSO REVIEWED THE POSSIBILITY OF TAKING X-RAYS AND THE POSSIBILITY OF FLUID BECAUSE THE PATIENT FELT STIMULATION AT THE POCKET AND HAD FLUCTUATING IMPEDANCES. THE REP DIDN'T THINK FLUOROSCOPY WAS NECESSARY BECAUSE THEY DIDN'T THINK THE LEAD COULD HAVE MOVED. THE REP LATER STATED THAT THE HEALTHCARE PROFESSIONAL (HCP) WOULD CONSIDER LOOKING AT AN IMAGE OF THE LEAD. THE PATIENT WAS GOING TO REMAIN WITH THEIR PROGRAMMING FOR NOW AND SEE IF/HOW THE STIMULATION SENSATION CHANGES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714851 ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37703 00643169107793

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR