BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5663100 · Received May 18, 2016

    Report

    Report Number
    3004209178-2016-09718
    Event Type
    Injury
    Date Received
    May 18, 2016
    Date of Event
    January 1, 2009
    Report Date
    May 18, 2016
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3888-45, LOT# V062395, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-45, LOT# V123646, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V109247, IMPLANTED: (B)(6) 2008, 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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FAILED BACK SURGERY SYNDROME. IT IS NOTED THAT THE PATIENT'S TIMELINE CONTINUOUSLY CHANGES. IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. THERE WAS A LOSS OF THERAPEUTIC EFFECT AND ACUTE PAIN IN THE LOWER BACK, HIPS, AND LEGS. INITIALLY, FOR THE FIRST YEAR AND INTO THE 2ND YEAR, THE PATIENT'S THERAPY WAS HELPING; HOWEVER OVER TIME THE THERAPY STOPPED HELPING WITH HER PAIN. THE PATIENT REPORTED, "IT'S LIKE YOUR BODY OR MIND GETS USED TO IT." THE PATIENT DECIDED TO TURN STIMULATION OFF IN THE (B)(6) OF 2012 AND HADN'T TRIED USING IT SINCE. THE PATIENT WENT TO TURN IT ON, ON (B)(6) 2013, SAW THAT STIMULATION WAS ON, BUT DID NOT FEEL ANYTHING. THE PATIENT CONTINUED TO KEEP UP ON HER RECHARGING SESSIONS. THE PATIENT'S STIMULATION WAS ON AND SHE WAS AT 10.5 VOLTS. THE PATIENT ONLY HAD 1 PROGRAM TO CHOOSE FROM. THE PATIENT REPORTED SEEING A LIGHTNING BOLT, BUT NOT FEELING STIMULATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015 REPORTED THAT THE PATIENT HADN'T USED HER STIMULATOR FOR A LONG TIME, BUT THAT SHE HAD BEEN RECHARGING THE IMPLANTABLE NEUROSTIMULATOR REGULARLY EVEN THOUGH SHE HADN'T BEEN USING IT. SHE HAD NOT USED HER STIMULATOR IN A COUPLE OF YEARS. THE PATIENT WANTED TO SEE IF THE STIMULATOR WOULD HELP AGAIN SINCE SHE HADN'T USED IT IN A COUPLE OF YEARS. THE PATIENT WAS ABLE TO SYNC TO THEIR IMPLANTABLE NEUROSTIMULATOR WITH THE PATIENT PROGRAMMER WHICH STATED THAT THEIR STIMULATION WAS OFF AND SET AT 10.5 VOLTS. THE PATIENT DECREASED THE STIMULATION TO 5.0 VOLTS AND TURNED THE STIMULATION ON, BUT DID NOT FEEL STIMULATION. THE PATIENT INCREASED THE STIMULATION TO SEE IF SHE COULD FEEL ANYTHING, BUT SHE COULD NOT. THE PATIENT STATED THAT SHE COULD INCREASE THE STIMULATION TO 10.0 VOLTS, BUT SHE WON'T FEEL STIMULATION. THE PATIENT REPORTED THAT THIS IS THE REASON THAT THE PATIENT HAD STOPPED USING THE STIMULATOR A COUPLE OF YEARS AGO BECAUSE SHE WASN'T FEELING STIMULATION, EVEN THOUGH SHE HAD IT AT 10 OR 10.5 VOLTS. THE PATIENT HAD NOT SEEN HER MANAGING HEALTH CARE PROVIDER IN YEARS AND WAS ADVISED TO FOLLOW UP WITH HER HEALTH CARE PROVIDER. THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT ON (B)(6) 2015 TO REPROGRAM HER. THE PATIENT WAS GETTING GOOD STIMULATION FOLLOWING THE REPROGRAMMING, AND IT WAS CONFIRMED THAT THE RECHARGER WAS WORKING FINE. THE PATIENT FURTHER REPORTED ON (B)(6) 2016 THAT SHE DID NOT USE THE THERAPY AND WILL BE HAVING IT REMOVED. THE STIMULATION WAS CURRENTLY OFF. IT WAS REVIEWED WITH THE PATIENT THAT SHE SHOULD CONTINUE TO RECHARGE HER DEVICE UNTIL IT IS EXPLANTED. THE PATIENT WAS TOLD DURING REPROGRAMMING (AT MINIMUM OF A YEAR OR MORE AGO) THAT ONE LEAD WAS NOT RESPONDING TO ANY PROGRAMMING AND THAT A COUPLE OF LEADS WERE NOT ATTACHED TO ANYTHING. THE HEALTH CARE PROVIDER WANTED TO LEAVE THE LEADS IN, BUT THE PATIENT WANTED ALL ITEMS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317930 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 54 YR Required Intervention