BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3081002 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06964
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 9, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 399860, LOT# N27158, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2013. IT WAS STATED THAT THE CAUSE OF THE POWER ON RESET (POR) WAS UNKNOWN. THE PATIENT WAS REPORTEDLY DOING FINE AND THE DEVICE WAS WORKING FINE. THE PATIENT NO LONGER HAD ANY CONCERNS WITH HIS DEVICE OR THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FOUND REPORTED THAT THERE WAS A COMMUNICATION ISSUE WITH THE STIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT FELT STIMULATION SINCE YESTERDAY. IT WAS STATED THAT THE PATIENT HAS NOT BEEN ABLE TO GET HIS IMPLANT TO CHARGE. IT WAS NOTED THAT THE LAST SUCCESSFUL RECHARGE WAS A WEEK AGO SUNDAY; AS THE PATIENT USUALLY RECHARGES ON SUNDAYS. IT WAS FURTHER STATED THAT NOTHING HAPPENED WHEN THE PATIENT PRESSED THE BUTTON TO START A RECHARGE. IT WAS ALSO NOTED THAT THE PATIENT DID NOT HAVE THE ANTENNA LOCATE (AL) FEATURE ON HIS MODEL OF RECHARGER. IT WAS ADDED THAT THE PATIENT USED TO HAVE TO ONLY RECHARGE ONCE A MONTH, BUT NOW HAD TO CHARGE EVERY WEEK. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED THAT NEW PROGRAMMER AND RECHARGER,BUT THEY DID NOT WORK. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS STATED THAT THE 'CALL YOUR DOCTOR' ICON WAS ON THE SCREEN. A POWER-ON-RESET (POR) CONDITION WAS NOTED. IT WAS STATED THAT AN OVERDISCHARGE WAS SUSPECTED. IT WAS ALSO STATED THAT THE USE OF THE AL FEATURE RESULTED IN A POR SCREEN, WHICH LEAD TO A NORMAL RECHARGING SCREEN. THE PATIENT WAS ABLE TO GET 8 COUPLING BARS. THIS CONFIRMED THAT THE DEVICE WAS NOT OVERDISCHARGED. IT WAS LATER REPORTED THAT WHEN THE PATIENT'S DEVICE BATTERY GOT TO A QUARTER FULL, THE STIMULATION STOPPED AND WOULD THEN RESTART. IT WAS STATED THAT THIS WAS HOW THE PATIENT KNEW WHEN TO RECHARGE. IT WAS ADDED THAT AS SOON AS THE STIMULATION STOPS, THE PATIENT WENT DOWN TO HIS KNEES DUE TO THE PAIN. THE AL FEATURE WAS USED AND RESULTED IN A 'WARNING POR' SCREEN, WHICH THE PATIENT HAD NEVER SEEN BEFORE. PATIENT SERVICES TOLD THE PATIENT THAT THIS POR COULD ONLY BE CLEARED BY THE PHYSICIAN. IT WAS NOTED THAT THE PATIENT WAS CURRENTLY TAKING ORAL PAINKILLERS (HYDROCODONE). THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182368 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR