BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3973547 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13830
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 11, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE RECHARGER. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3998, LOT# V026436, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3998, LOT# V026436, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVERDISCHARGE WAS SUSPECTED DUE TO PATIENT COMPLIANCE AND EDUCATION. IT WAS NOTED THE LAST SUCCESSFUL RECHARGING SESSION WAS THREE YEARS PRIOR TO CALL. IT WAS REPORTED THE PATIENT DID NOT KNOW WHERE THEIR PROGRAMMER WAS. IT WAS NOTED STIMULATION WAS WORKING WELL, BUT THEN THE PATIENT DID NOT NEED IT AND STOPPED USING IT. IT WAS REPORTED THE PATIENT¿S PAIN WAS RETURNING AND WANTED TO USE STIMULATION AGAIN. IT WAS NOTED A NERVE IN THEIR LEFT LEG WAS BOTHERING THEM. IT WAS REPORTED THE LOCATION OF THE STIMULATOR WAS A PROBLEM AND RECHARGING TOOK HOURS. IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH THE DOCTOR. IT WAS NOTED THAT THE APPOINTMENT DATE WAS 2014-(B)(6). THE PATIENT ALSO WROTE, ¿THANK YOU FOR CARING BUT I WON¿T BE USING THE DEVICE IN THE FUTURE.¿ THE PATIENT NOTED THAT THE DOCTOR WAS NO LONGER USING THE DEVICE, WAS NOT THE PATIENT¿S DOCTOR NOR DID THE DOCTOR WORK IN PAIN MANAGEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451454 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR