BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3951232 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13389
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 30, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS EZW-URINARY DYSFUNCTION/SACRAL NERVE STIM. CONCOMITANT PRODUCTS: PRODUCT ID 7435, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-33, LOT # V388976, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 748910, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 748910, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3889-28, LOT # V462946, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THE PATIENT WAS HAVING PROBLEMS WITH THEIR STIMULATION. IT WAS STATED THE PATIENT WAS ON VACATION ON A TOUR BUS RIDE AND THEY HAD THE BUMPIEST AND MOST AWFUL RIDE AND THEIR BACK WAS IN SPASMS. REPORTEDLY, THIS LASTED FOR ABOUT 3-4 DAYS AND GIVEN TIME THEIR BACK SMOOTHED OUT BUT THE PATIENT NEVER FELT 100 PERCENT. IT WAS STATED THE PATIENT WAS ABLE TO BEND AND STUFF BUT IT WAS NOT WORKING. IT WAS NOTED THAT IN MAY THE PATIENT HAD BACK SPASMS AGAIN BUT THEY WERE NOT SURE OF WHY AND NOTHING SEEMED TO AGGRAVATE IT. IT WAS STATED THE PATIENT WENT TO THEIR DOCTOR THE MONDAY PRIOR TO REPORT OR THE MONDAY BEFORE AND THEY STATED THERE WAS NOT RESIDUAL STIMULATION. IT WAS NOTED THE PATIENT¿S DOCTOR STATED EVERYTHING LOOKED FINE. IT WAS NOTED THAT SINCE THE PAST THURSDAY OR FRIDAY THE PATIENT¿S PAIN HAD BEEN GETTING WORSE AND WORSE. REPORTEDLY, THE PATIENT¿S DOCTOR SAID THE LEAD COULD BE DISLODGED. THE PATIENT STATED THEY WERE STILL FEELING STIMULATION IN THEIR BACK AND THEY WERE GETTING THE FLUTTER WHERE THEY NORMALLY DID. IT WAS NOTED THE PATIENT HAD X-RAYS DONE BUT THEY HAD NOT YET BEEN VIEWED BY THEIR DOCTOR. THE PATIENT TURNED OFF THEIR STIMULATION AND THEIR BACK PAIN WAS LOOSER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428384 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR