BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4130193 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-17992
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 9, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-33, LOT# V394049, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3888-33, LOT# V394049, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3888-33, LOT# V394049, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATORS (INS) WAS IN ITS FIRST CONFIRMED OVERDISCHARGE (OD) CONDITION. IT WAS NOTED THAT THE PATIENT HAD STOPPED USING THEIR INS AROUND LAST CHRISTMAS AND NOW WANTED TO USE IT AGAIN. THE IMPORTANCE OF RECHARGING WAS EXPLAINED TO THE PATIENT EVEN WHEN THE DEVICE IS NOT BEING USED. TWO PHYSICIAN MODE RECHARGE (PMR) PROCEDURES WERE ATTEMPTED BUT DID NOT SUCCESSFULLY RESET THE DEVICE. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY AT THE TIME OF REPORT AND WAS TO FOLLOW UP WITH THEIR PHYSICIAN TO DISCUSS POSSIBLE REPLACEMENT OF THE DEVICE. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN OUTCOME 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
    608402 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