BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4210665 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20607
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 7, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377775, LOT# V014386, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377775, LOT# V021102, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LEVEL HAD DEPLETED. THE PATIENT HAD THEN ATTEMPTED TO RECHARGE THE INS AND A ¿CALL YOUR DOCTOR¿ SCREEN APPEARED SHOWING AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE, WHICH HAD FIRST BEEN SEEN ABOUT A MONTH AGO. THE INS BATTERY CHARGE WOULD ONLY LAST FOR 5 DAYS, WHICH HAD STARTED TO OCCUR A YEAR AGO. THE INS WAS NOTED TO HAVE NOT TAKEN CARE OF ALL OF THE PAIN, THOUGH THE PATIENT STATED THAT ¿WHEN IT DOES, IT SURE DOES.¿ THE PATIENT¿S PAIN WAS NOTED TO HAVE HAD 5 DIFFERENT SOURCES, BUT ¿THE ONE THAT IT TAKES CARE OF, IT DOES A MARVELOUS JOB.¿ THE PATIENT WAS ABLE TO TELL WHEN THE STIMULATOR WOULD TURN OFF BECAUSE ¿IT GETS TO THE POINT THAT [THE PATIENT] DIDN¿T EVEN NOTICE IT WAS ON ANYMORE, SO SOMETIMES IT WOULD TURN OFF AND [THE PATIENT] WOULDN¿T REALLY NOTICE IT AND SOMETIMES IT WOULD HAVE TO BE OFF FOR AN HOUR FOR [THE PATIENT] TO REALLY REALIZE THAT [THE PATIENT¿S] PAIN LEVEL HAD GONE UP TO THE POINT THAT [THE PATIENT] WAS LIKE, OKAY [THE PATIENT¿S ] MEDS WEREN¿T WORKING, [THE PATIENT¿S] PLUS MEDS WEREN¿T WORKING, AND THEN ALL OF THE SUDDEN [THE PATIENT] REALIZED THE INS WAS DEAD.¿ THE PATIENT¿S INS WAS NOTED TO HAVE MADE A HUGE DIFFERENCE WHEN IT WAS TURNED ON. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693605 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR