BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3190749 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10914
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 4, 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 PRODUCTS: PRODUCT ID 37742, SERIAL #(B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377860, LOT # V021898, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377860, LOT # V021898, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT HAD A NON-DEVICE RELATED CONFLICT AND WAS UNABLE TO MEET WITH THE MANUFACTURER REPRESENTATIVE ¿LAST WEEK.¿ THE MEETING WAS SUPPOSED TO BE A FOLLOW UP AFTER THE PATIENT HAD COMPLETED THE RECHARGING OF HER BATTERY. THE PATIENT INTENDED TO CONTACT THE MANUFACTURER REPRESENTATIVE WHEN SHE BECAME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL 1 TO 1.5 MONTHS AGO. THE PATIENT STATES THAT SHE HAD BEEN CHARGING HER DEVICE BUT COULD NOT GET IT TO CONNECT WITH THE PROGRAMMER FOR THE PAST WEEK. IT WAS NOTED THAT SHE FULLY CHARGED LAST WEEK AND SHE WAS SEEING THE POOR COMMUNICATION SCREEN ON THE PROGRAMMER. THE PATIENT STATED SHE LOST (B)(6). IT WAS REPORTED THAT THE PATIENT LOST TELEMETRY WITH HER IMPLANTABLE NEUROSTIMULATOR (INS) (BOTH IMPLANTABLE NEUROLOGICAL STIMULATOR RECHARGER (INSR) AND PATIENT PROGRAMMER) AFTER A FALL THAT OCCURRED ABOUT A MONTH AGO WHERE SHE FELL FORWARD HARD ON THE CONCRETE. IT WAS NOTED THAT THE INS WAS CHARGED UP AT THE TIME OF THE FALL, BUT THE PATIENT DID NOT HAVE ANY COMMUNICATION WITH HER SYSTEM AFTER THE FALL. IT WAS NOTED THAT THE PATIENT HAD FALLEN BEFORE ON HER INS IN THE PAST, BUT IT HADN¿T AFFECTED HER COMMUNICATION WITH HER DEVICE. IT WAS REPORTED THAT A TRICKLE CHARGE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289977 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR