BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3213516 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11497
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 17, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID 37752, SERIAL# (B)(4): PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009: PRODUCT TYPE LEAD; PRODUCT ID 3550-29, LOT# N217695, IMPLANTED: (B)(6) 2009: PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IT WAS TAKING THE PATIENT LONGER TO CHARGE THEIR DEVICE AND THE LAST TWO TIMES THE PATIENT CHARGED IT TOOK OVER SEVEN HOURS. IT WAS STATED ONE OF THE TIMES IT WAS BECAUSE THE IMPLANTABLE NEUROSTIMULATOR (INS) GOT TOO LOW. IT WAS NOTED THE PATIENT CHARGED THE WEEK PRIOR TO REPORT AND IT TOOK 1.5-2 HOURS AND WHEN THEY CHARGED THE DAY BEFORE REPORT IT TOOK ¿FOREVER.¿ REPORTEDLY, THE PATIENT TURNS THEIR STIMULATION OFF WHILE RECHARGING AND THEY ONLY HAVE IT ON WHEN THEY ARE ACTIVE BECAUSE ¿SHE CAN¿T LAY HERE AND LET IT ZAP HER.¿ IT WAS NOTED THE PATIENT HAD STARTED USING THEIR STIMULATION MORE OVER THE LAST FEW MONTHS BECAUSE SHE IS MORE ACTIVE. IT WAS REPORTED THE PATIENT WENT FROM CHARGING ONCE A MONTH WHEN THEY GOT THEIR DEVICE IMPLANTED TO EVERY 3 WEEKS, THEN EVERY 2 WEEKS. IT WAS NOTED THE PATIENT¿S RIGHT LEG WAS WORSE THAN THEIR LEFT AND THEY DIDN¿T TURN THEIR STIMULATION UP HIGHER THAN 1.2 VOLTS ON THE LEFT BUT THEIR RIGHT SIDE WAS TURNED UP TO 1.9 VOLTS. IT WAS STATED THE ¿TINGLING/ZAPPING¿ DIDN¿T BOTHER THE PATIENT AND WOULD PUT HER TO SLEEP. THE PATIENT STATED THEIR DEVICE WAS WORKING AND THE STIMULATION WAS NOT UNCOMFORTABLE OR PAINFUL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT NO INCIDENT WAS EVER REPORTED TO THEM. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311964 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