BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3081099 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06967
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3887-45, LOT# V048045, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 74001, LOT# N314868, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECHARGING THEIR DEVICE MORE THAN EXPECTED. IT WAS STATED THATTHIS BEGAN ABOUT "3 MONTHS AGO". IT WAS STATED THAT "FOR THE PAST THREE MONTHS" THE PATIENT COULD NOT GET THE CHARGE LEVEL ABOVE 50%. THE LAST RECHARGE SESSION LASTED 91 MINUTES, BUT THERE WERE ZERO COUPLING BARS. IT WAS CONFIRMED THAT THE RECHARGER WAS WORKING "OK". IT WAS ALSO REPORTED THAT THE PATIENT WAS "SHOCKED" IN HIS HAND BUT EQUIPMENT HE WORKED ON AT HIS WORK. IT WAS STATED THAT THISWAS NOT RELATED TO THE STIMULATION THERAPY. IT WAS STATED THAT THE SHOCK OCCURRED 3 MONTHS AGO, THE SAME TIME THAT THE RECHARGING ISSUES STARTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS DOING WELL. IT WAS ALSO STATED THE PATIENT WAS SHOCKED BY EQUIPMENT THEY USED AT WORK AND THOUGHT THAT IT MAY HAVE DAMAGED THE BATTERY OR CAUSED THE DIFFICULTY WITH CHARGING. IT WAS NOTED THE IMPEDANCES WERE NORMAL AND THE PATIENT¿S RECENT RECHARGE SESSIONS SHOWED THE PATIENT WAS ONLY CHARGING FOR 15-20 MINUTES AT A TIME WHICH IS WHY THEY WERE NOT GETTING TO A FULL CHARGE. IT WAS STATED THE PATIENT WAS GIVEN FURTHER RECHARGER EDUCATION AND WAS ABLE TO CHARGE NORMALLY. IT WAS REPORTED THE PATIENT¿S STIMULATION THERAPY WAS NORMAL AND EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181991 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 00057 YR