BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3021976 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04265
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    October 24, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIDN'T USE THEIR DEVICE OFTEN BECAUSE THE STIMULATION WAS SO STRONG THAT IT CAUSED PAIN WHICH SOMETIMES LASTED A WEEK. THE HEALTHCARE PROVIDER REPORTEDLY SAID THE PAIN WAS "EXPECTED DUE TO THE AMOUNT OF NERVE DAMAGE AROUND L3-5. IT WAS ALSO REPORTED THE PATIENT FELT HER CURRENT DEVICE WAS "100 TIMES MORE POWERFUL" THAN A PREVIOUS DEVICE AND THE SUBSEQUENT PAIN WAS MORE INTENSE. IT WAS ALSO REPORTED THE PATIENT'S RECHARGER WAS FUNCTIONING PROPERLY BUT THE PATIENT HAD DROPPED HER RECHARGER A COUPLE TIMES ON A HARDWOOD FLOOR AND A SMALL CRACK ON THE ANTENNA WAS NOTED. THE PATIENT ALSO STATED THEY HAD BEEN CHARGING WHILE LYING DOWN AND WAS ADVISED TO NOT DO THAT. IT WAS REPORTED THE PATIENT HAD BEEN ACCIDENTALLY INTERRUPTING HER CHARGING SESSIONS BY PRESSING THE "X" BUTTON ON THE RECHARGER. THE PATIENT ALSO REPORTED THEIR LONGEST CHARGING SESSION WAS 7-8 HOURS. THE PATIENT REPORTED THEIR BATTERY LOST CHARGE EVEN WHEN THEY WEREN'T USING IT AND THE PATIENT STATED THEIR PREVIOUS DEVICE HELD A CHARGE "BETTER THAN THIS ONE." THE PATIENT ALSO STATED THEY WERE REPROGRAMMED TO SWITCH FROM THREE AREAS OF "WIDTH" TO ONLY TWO. IT WAS REPORTED THE PATIENT EXPERIENCED A PULSATION UNDER HER LEFT BREAST WHEN THE STIMULATION WAS INCREASED TOO HIGH. THE HEALTHCARE PROVIDER REPORTEDLY STATED THE PATIENT WOULD REQUIRE SURGERY TO ADJUST THE LEAD IF THE SYMPTOM REMAINED, BUT ALSO STATED THEY HAD DIFFICULTY PLACING THE LEAD DUE TO SCAR TISSUE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT'S "TANK" WAS EMPTY ON THEIR "INTERNAL PART". IT WAS NOTED THAT THE PATIENT NEVER HAD TO WEAR THE RECHARGER SO LONG BEFORE BECAUSE IT "USUALLY WORKS QUICKER". IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) CONTINUED TO LOSE CHARGE EVEN WHEN THE PATIENT WASN'T "USING IT".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEIR PAIN IS WORSE WITHOUT THEIR INS. NO FURTHER ISSUES WERE NOTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED BURNING INTENSIFY IN THE PATIENTS QUADRICEP(S) WHEN STIMULATIONS WAS OFF OR TOO LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123803 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1