BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 4243433 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21310
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    April 12, 2010
    Report Date
    October 17, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V414754, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3093-28, LOT# V414754, 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: 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT TURNED THE DEVICE OFF. THE PATIENT HAS HAD PROBLEMS SINCE IMPLANT. THEY HAVE HAD CONSTIPATION, DIARRHEA, AND PAIN. IT WAS ADDED THAT THEY COULD NOT SLEEP. IT WAS NOTED THE PATIENT WAS TAKING MEDICINES AND WAS READY TO HAVE THE DEVICE TAKEN OUT. IT WAS ADDED THE PATIENT HAS HAD 3 OTHER OPERATIONS PRIOR TO HAVING THE DEVICE. ABOUT TWO WEEKS LATER, IT WAS INDICATED THE PATIENT COULD COME IN FOR REPROGRAMMING, BUT WOULD NEED AN APPOINTMENT. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT¿S SYMPTOMS CAME BACK BECAUSE THEY DECREASED THE STIMULATION TO STOP THE CONSTIPATION SIDE EFFECTS FROM THE STIMULATION. THE PATIENT PUSHED THE STIMULATION LOW BECAUSE THEY DIDN¿T LIKE TO BE CONSTIPATED AND THEY KEPT IT VERY LOW BECAUSE IT WAS NOT HELPING MORE. THE PATIENT¿S BLADDER SYMPTOMS CAME ON RIGHT WHEN THEY TURNED THE STIMULATION ON REALLY LOW AND INCREASED ABOUT 2 MONTHS AGO. THE PATIENT WAS UP AND DOWN WITH THE STIMULATION AND IT WOULDN¿T HELP WITH THE CONSTIPATION. ONCE IN A WHILE, THE PATIENT HAD TO URINATE BECAUSE IF THEY WAITED, THEY STARTED TO DRIBBLE. THE PATIENT WANTED TO KNOW HOW TO CONTROL THE STIMULATION, SO IT COULD HELP WITH THE BLADDER AND NOT GET CONSTIPATED. THE PATIENT DID HAVE URGENCY AND FREQUENCY AND DIDN¿T KNOW HOW TO REGULATE IT. SOMETIMES WHEN THE PATIENT WAS SITTING IN A POSITION, IT GAVE THEM A JOLT AND THEY KNEW IT WAS ALIVE. IT WAS MENTIONED THAT THE PATIENT GOT HURT ON THEIR LEFT SHOULDER AND THEIR HEALTH CARE PROVIDER (HCP) WANTED TO DO AN MRI AND THEY WANTED TO IF THEY COULD GET ONE. THE MRI WAS UNRELATED TO THE DEVICE OR THERAPY AS THE PATIENT HAD AN INJURY FROM USING WEIGHTS. THE PATIENT HAD A BLADDER INCONTINENCE STIMULATION AND DIDN¿T KNOW IF THE MRI WOULD PULL IT OUT. THE PATIENT HAD A PAIN STIMULATOR BEING USED FOR INCONTINENCE. NO OUTCOME OR INTERVENTIONS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726312 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 00073 YR