BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4200516 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20369
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    October 3, 2014
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE IMPEDANCE READINGS GREATER THAN 2000 OHMS. THE PATIENT EXPERIENCED RIGHT SIDE BACK PAIN AND PAIN AT LEAD SITE. THIS WAS A STABBING PAIN WITH STIMULATION TURNED ON AS WELL AS STIMULATION TURNED OFF THE PATIENT DID NOT FEEL STIMULATION WHEN THE IMPLANT WAS TURNED ON BUT HAD TO LEAN BACK TO FEEL IT. THE PATIENT WAS UNCOMFORTABLE AT LEAD SITE AND STILL FELT UNCOMFORTABLE. THIS STARTED 11 WEEKS AGO, NO FALLS REPORTED. IT WAS THOUGHT THAT THE IMPEDANCE ISSUE WAS IN ASSOCIATION SAME TIME AS REPORTS OF PATIENT SYMPTOMS. IT WAS REPORTED THAT IT WAS LIKE INTERMITTENT STIMULATION IN ADDITION TO THE STABBING PAIN. ELECTRODE IMPEDANCE TEST WAS DONE AT 1.15V AND COULD NOT TOLERATE 3.0V. GREATER THAN 2000 OHMS WERE SEEN ON CONTACT 0, 10 AND 4, 6, 7 WHEN SCROLLING THROUGH ALL REFERENCE VALUES. OTHER VALUES WERE MORE IN RANGE OF 1000 TO 1500 OHMS. THEY WERE NOT USING 0, 4, 5, 6, 7, 10 FOR PROGRAMMING. THEY WERE USING 14 AND 15. THE OTHER ELECTRODES THAT WERE HIGHER UNFORTUNATELY COULDN¿T BE USED BECAUSE THEY HAD CAUSED RIB STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE FOR IMPEDANCES WAS UNKNOWN. THE PATIENT WAS NOT HAVING 50% REDUCTION AT THIS TIME AND WAS REFERRED BACK TO HER IMPLANTING PHYSICIAN FOR EVALUATION. THE PATIENT HAD AN APPOINTMENT ON (B)(6). NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GOING TO BE SEEN ON (B)(6) TO ATTEMPT "HD" REPROGRAMMING. THE PATIENT CALLED AND STATED THAT STIMULATION WAS STILL "SPUTTERING" AND "PINCHING." STIMULATION DID HELP THE PATIENT'S LEGS BUT STIMULATION WAS SPORADIC AND NOT COMFORTABLE. WITHIN A FEW DAYS RECENTLY SHE COULDN'T GET FEELING AT ALL WHEN SHE MOVED IN DIFFERENT POSITIONS AND WHEN ASKED IF SHE INCREASED THE STIMULATION AT ALL FIRST SHE SAID YES AND THEN SHE SAID "WELL NO." IT WAS NOTED THAT THE PATIENT'S SCOLIOSIS WAS SO PAINFUL BUT HER PHYSICIAN WOULDN'S OPERATE. THE PATIENT EITHER WANTED STIMULATION FIXED OR WANTED IT OUT. "STIMULATION WAS A FAILURE" PER THE PATIENT. THERE WERE NO FALLS REPORTED. THE MANUFACTURER'S REPRESENTATIVE (REP) LATER REPORTED THAT THE PATIENT MENTIONED THAT STIMULATION WAS SPUTTERING, GETTING WEAKER AND WEAKER, AND THEY WERE UNABLE TO FEEL STIMULATION. ALL ELECTRODE IMPEDANCE WERE TESTED AT 0.7 VOLTS AND SHOWED GREATER THAN 10,000 OHMS. IT WAS INCREASED TO THREE VOLTS AND ELECTRODE 8-15 SHOWED ALL WERE GREATER THAN 40,000 OHMS. ELECTRODE 0-7 HAD A RANGE FROM 26548-38214 OHMS WITH REFERENCE 0. REPROGRAMMING WAS DONE USING ELECTRODE 0/5 (26548 OHMS). THE REP. REPORTED INCREASED AMPLITUDE UP TO 10.5 VOLTS AND THE PATIENT CONTINUED TO FEEL NO STIMULATION. THERE WAS NO FALL/TRAUMA WHEN STIMULATION STARTED TO FADE. IT WAS LATER REPORTED THAT THE PATIENT SAW HER NEUROSURGEON ON (B)(6) AND HE DECIDED TO REVISE OR EXPLANT. THE PATIENT NOW REPORTED THAT SHE FELL AT HOME DEPOT WHEN SHE PREVIOUSLY REPORTED NO FALLS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT PATIENT SAW A SURGEON WHERE IT WAS FELT THE ISSUES WERE DUE TO THEIR BAD SCOLIOSIS AND THAT THE SURGEON COULD NOT PROVIDE ANY BETTER RESULTS FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). NO INTERVENTIONS WERE PLANNED FOR THE PATIENT. IT WAS NOTED THAT THE PATIENT¿S COMPLAINTS WERE AS BEFORE ALTHOUGH THEY STATED THAT THEY WERE SOMEWHAT IMPROVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679019 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention