BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2992085 · Received March 7, 2013

    Report

    Report Number
    3007566237-2013-00707
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND THEIR STIMULATION TURNED OFF A COUPLE TIMES PER DAY. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. IT WAS ALSO REPORTED THE PATIENT'S STIMULATION WAS THERAPEUTIC IN HER ARM WHEN TURNED ON, BUT SHE DID EXPERIENCE SOME POSITIONAL CHANGES IN STIMULATION. IT WAS REPORTED THE IMPEDANCE MEASUREMENTS WERE WITHIN RANGE AND THE PREDICTED LONGEVITY OF THE DEVICE WAS 65 MONTHS. IT WAS ALSO REPORTED THE PATIENT HAD AN APPOINTMENT SCHEDULED TO MEET WITH THE CLINICIAN ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED NO FURTHER INTERVENTION OR DIAGNOSTICS WOULD BE DONE FOR THE PATIENT BECAUSE THE PATIENT WAS STILL GETTING SUFFICIENT PAIN RELIEF WHEN THEY TURNED THE DEVICE BACK ON. IMPEDANCES PREVIOUSLY REPORTED WERE INCORRECT - IMPEDANCES ARE REPORTED AS WITHIN NORMAL RANGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT STIMULATION WAS TURNING OFF. IT WAS NOTED THAT THE PATIENT CHECKED HER IMPLANTABLE NEUROSTIMULATOR (INS) BY ATTEMPTING TO INCREASE STIMULATION AND THEN GETTING DENIED. THE PATIENT WOULD THEN TURN STIMULATION ON. IT WAS STATED THAT THE INS HAD 26 ACTIVATIONS TODAY (THE PATIENT TRACKED TURNING STIMULATION ON). THE PATIENT WAS IN A MOTOR VEHICLE ACCIDENT (B)(6) 2013, BUT THE ISSUE STARTED BEFORE THE ACCIDENT. IT WAS ALSO STATED THAT MOVEMENT AFFECTED STIMULATION. THE IMPEDANCES WERE CHECKED AND ARE AS FOLLOWS: C/0=3384 OHMS; C/1=540 OHMS BEFORE MVA AND ¿???¿ AFTER MVA; C/2=548 OHMS BEFORE MVA AND ¿???¿ AFTER MVA; C/3=550 OHMS BEFORE MVA AND 33 OHMS AFTER MVA; 0/1=¿???¿ BEFORE MVA AND 2259 OHMS AFTER MVA; 0/2=2236 OHMS BEFORE MVA AND 3384 OHMS AFTER MVA; 0/3=3384 OHMS BEFORE MVA AND 15 OHMS AFTER MVA; 1/2=741 OHMS BEFORE MVA AND 25 OHMS AFTER MVA; 1/3=836 OHMS BEFORE MVA AND 22 OHMS AFTER MVA; AND 2/3=665 OHMS BEFORE MVA AND 28 OHMS AFTER MVA. IT WAS LATER REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS ADVISED TO DISABLE THE ¿CONTROL MAGNET¿ FUNCTION (MAGNETIC REED SWITCH). THE PATIENT WOULD BE SEEN AGAIN ON (B)(6) 2013 TO SEE IF ANYTHING HAD CHANGED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2013 FOR TROUBLESHOOTING. IT WAS STATED THAT THE PATIENT WAS ¿VERY POSITIONAL WHEN IT CAME TO FEELING STIMULATION.¿ IT WAS FURTHER STATED THAT DEPENDING ON THE PATIENT¿S HEAD POSITION, STIMULATION WOULD GO ON AND OFF. IMPEDANCES WERE REPORTEDLY WITHIN NORMAL RANGE AND NO FURTHER DIAGNOSTICS WERE DONE. THERE WAS NO INTERVENTION PLANNED. THE PATIENT WAS INSTRUCTED TO KEEP STIMULATION AT A COMFORTABLE LEVEL TO PREVENT A SUDDEN ¿SURGE¿ OF STIMULATION WITH HEAD MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97791 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 7425

    Patients

    Seq Age Sex Outcome Treatment
    1