BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3802713 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08806
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 18, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID NEU_RECHARGER_ACC, SERIAL# UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, STARTING ABOUT 2 WEEKS PRIOR TO THE REPORT, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS), RECHARGER, AND PATIENT PROGRAMMER HAD NOT BEEN WORKING. IT WAS NOTED THAT IT WAS FINE AND THEN SUDDENLY IT WAS NOT WORKING ANYMORE. THE PATIENT WAS ASKED WHEN THE LAST TIME THEY FELT STIMULATION AND THE PATIENT RESPONDED THAT THEY WERE CONFUSED. IT WAS NOTED THAT THE LAST TIME THE PATIENT SUCCESSFULLY RECHARGED WAS 3 TO 4 WEEKS PRIOR TO THE REPORT. THE PATIENT WAS REPORTEDLY TOLD THAT ¿IF IT DOESN'T WORK IT NEEDS TO BE RECHARGED .... REPROGRAMMED.¿ THE PATIENT REPORTEDLY HAD BEEN TRYING TO RECHARGE FOR 2 WEEKS PRIOR TO THE REPORT BUT HAD NOT BEEN ABLE TO CHARGE. IT WAS FURTHER REPORTED THAT THE PATIENT PROGRAMMER WOULD NOT LIGHT UP AT ALL. THE PATIENT REPORTEDLY REPLACED THE BATTERIES WITH NEW ONES. IT WAS NOTED THAT THE PATIENT PROGRAMMER HAD NOT BEEN DROPPED OR GOTTEN WET. IT WAS LATER REPORTED THAT THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR OR A MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THEY HAD AN APPOINTMENT ON (B)(6) 2014. IT WAS THEN REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY AND THEY HAD AN APPOINTMENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280976 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 00039 YR