BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4766468 · Received May 12, 2015

    Report

    Report Number
    3004209178-2015-08980
    Event Type
    Injury
    Date Received
    May 12, 2015
    Report Date
    April 17, 2015
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-33, LOT# V711815, IMPLANTED: 2012-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 355531, LOT# N322330, IMPLANTED: 2012-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2015-(B)(6) PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3888-33, LOT# V279838, IMPLANTED: 2012-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V851639, IMPLANTED: 2012-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THEY THOUGHT AT FIRST THEY GOT SOME RELIEF WITH THEIR STIMULATOR BUT NOT REALLY. IT WAS THOUGHT THAT THEIR MEDICATIONS WERE CUT DOWN TOO EARLY. IT WAS WONDERED IF IT WAS PSYCHOLOGICAL, RIGHT AWAY THEY FELT IT WAS HELPFUL AND THEIR MEDICATIONS WERE WORKING BETTER AND WAS FEELING BETTER THAN THE DECISION WAS MADE TO WEAN HIM OFF THE PAIN MEDICATIONS AND THEY THOUGHT IT WAS DONE TOO SOON. THE PATIENT WANTED TO TALK TO SOMEONE WITH LOW BACK PAIN WHO HAD PERIPHERAL SYSTEM AND MOVED TO EPIDURAL ONE. 2015-(B)(6) (B)(4): IT WAS REPORTED THAT THE DEVICE WAS REMOVED ON (B)(6) 2015. ALL FOUR LEADS AND THE STIMULATOR WERE REMOVED. IT WAS REMOVED BECAUSE THEY DID NOT REALLY GET ANY BENEFIT FROM IT AND IT STARTED TO ANNOY THEM. THE PAIN THE DEVICE WAS IMPLANTED TO TREAT WAS ALL ACROSS THEIR LOW BACK IN THEIR LEFT FLANK. THE PAIN IN THE LEFT FLANK WAS THE WORST. THEY HAD TWO LEADS THAT WERE VERTICAL FROM THEIR HIP UP AND TWO MORE THAT WERE HORIZONTAL DOWN ACROSS THEIR BACK. THE PATIENT WOULD BEN AND REACH OR EXERCISE AND THEY WOULD GET ZAPPED RIGHT WHERE THE TWO HORIZONTAL LEADS WERE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310904 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention