BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4103185 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17421
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    October 2, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S STIMULATION WOULD SOMETIMES SPEED UP ON ITS OWN. WHEN THE PATIENT SYNCHED THE PROGRAMMER TO THE IMPLANTABLE NEUROSTIMULATOR (INS) IT SHOWED SHE WAS IN THE PROPER POSITION AND THE SPEEDING UP SENSATION STOPPED AND WOULD GO BACK TO NORMAL. THIS STARTED ABOUT 1 MONTH AFTER THE PATIENT GOT THE DEVICE AND THE PATIENT REPORTEDLY MET WITH A MANUFACTURER REPRESENTATIVE (REP) AT THAT TIME. THE PATIENT WAS SEEN ON (B)(6) 2013 FOR INTERROGATION OF THE DEVICE DUE TO ¿SPEEDING UP.¿ THEY ENDED UP DELETING ALL THE PROGRAMS THE PATIENT HAD AND STARTING FROM SCRATCH. THE PATIENT WAS REPROGRAMMED AND WAS RECEIVING EFFECTIVE STIMULATION AFTER REPROGRAMMING. IT SEEMED FINE AFTER THAT UNTIL ABOUT LAST WEEK WHEN IT STARTED UP AGAIN. THE PATIENT HAD NOT MET WITH A REP IN ABOUT 1 YEAR. THE PATIENT MEETS WITH HER HEALTH CARE PROVIDER (HCP) EVERY MONTH, AND WAS DIRECTED TO GET IN TOUCH WITH A REP ABOUT THE ISSUE. THE PATIENT THEN RECEIVED A NEW PROGRAMMER IN THE MAIL. SINCE SHE STARTED USING THE NEW PROGRAMMER, EVERYTHING, INCLUDING HER DEVICE, WAS WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581552 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 00041 YR