BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 5326821 · Received December 24, 2015

    Report

    Report Number
    3004209178-2015-25582
    Event Type
    Injury
    Date Received
    December 24, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF-LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093-28, LOT# J0327080V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# V098959, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. 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

    THE CONSUMER REPORTED THAT SHE STARTED FEELING UNCOMFORTABLE/PAIN IN THE LOWER BACK. THIS WAS MORE ON THE LEFT SIDE WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN 2014. IN THE LAST NINE MONTHS (LATER CLARIFIED TO BE (B)(6) OF 2015) THE PATIENT EXPERIENCED A LOT OF FALLS AND LANDED MANY TIMES ON THE LEFT SIDE WHERE THE INS WAS. ON (B)(6) 2015, SHE BROKE HER RIGHT ANKLE AND HAD TO GO TO THE EMERGENCY ROOM. THE LOWER BACK PAIN WAS ALREADY THERE BEFORE THE FALLS STARTED TO HAPPEN. THEY NEVER TOOK AN X-RAY OR CT SCAN OF THE LOWER BACK. SHE THEN ADDRESSED IT WITH HER REGULAR HEALTH CARE PROFESSIONAL (HCP) AND HE PRESCRIBED THERAPY FOR HER NECK AND THE LOWER BACK. THAT SEEMED TO HELP TEMPORARILY BUT NOT REALLY. FOR THE LAST TWO WEEKS, SHE HAD BEEN IN A TREMENDOUS AMOUNT OF LOWER BACK PAIN. IT WAS GETTING WORSE DAILY AND SHE COULD NOT WALK. THE LEFT SIDE HAD MUSCLE SPASMS GOING UP AND DOWN AND ACROSS. THEY WERE WOBBLING IN THE PAIN. LAST NIGHT THEY THOUGHT THEY WERE GOING TO HAVE A HEART ATTACK BECAUSE OF THE RADIATING PAIN. THE BACK PAIN WAS THERE BEFORE THE FALLS. THE PATIENT WAS CONCERNED THAT THE FALLS COULD HAVE CAUSED THE DAMAGE TO HER DEVICE. IT WAS NEVER CHECKED. DURING THE PHYSICAL THERAPY AFTER BREAKING HER ANKLE, SHE USED A TENS UNIT AND HEAT. THIS FINISHED A MONTH PRIOR TO (B)(6) 2015. THEY KEPT THE BIG THINGS WRAPPED AROUND HER BODY IN A MACHINE. THE TENS AND HEAT WERE NOT USED AT THE SAME TIME. HOWEVER, THERE WAS A STIMULATION IN THE HEAT MACHINE. THE PATIENT COULD FEEL THE SPARKS HIT THEIR BODY ACROSS THE LOWER BACK. THE TENS UNIT WAS USED ON THE CENTER OF HER NECK, SHOULDER, AND BACK. SHE GOT MORE ON THE LOWER BACK AFTER A COUPLE OF WEEKS. THE PATIENT WAS CONCERNED WHETHER THE PHYSICAL THERAPY MIGHT HAVE DONE ANY DAMAGE TO HER DEVICE. SHE HAD NOT SEEN THE HCP IN A LONG TIME AND WAS GOING TO SEE THE HCP ON (B)(6) 2016. IT WAS ALSO NOTED THAT THE PATIENT WAS DISABLED AND HAD PERIPHERAL NERVE DAMAGE. SHE HAD NERVE DAMAGE TWO INCHES ABOVE HER KNEES ALL THE WAY DOWN. SHE WALKED WITH THE PLASTIC LEG BRACES AND A CANE. THE INDICATION-FOR-USE (IFU) WAS URINARY DYSFUNCTION/SACRAL NERVE STIM. NO OUTCOME, CIRCUMSTANCES THAT LED TO THE EVENT, OR STEPS TAKEN TO RESOLVE THE ISSUE 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 FROM THE PATIENT REPORTED THAT THE PATIENT ENDED UP HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) TAKEN OUT ON (B)(6) 2016 BECAUSE OF PAIN AND PROBLEMS. SHE DID NOT HAVE THE LEADS TAKEN OUT AND WAS CONCERNED ABOUT EVER NEEDING A MRI. THE PATIENT STILL HAD PAIN ON THE LEFT SIDE WHERE THE INS WAS TAKEN OUT. THE PATIENTS STATED THAT MAYBE A LEAD WAS SITTING ON A NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851354 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention