BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3122112 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07968
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    May 1, 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 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATION ¿SEEMED TO HAVE A PROBLEM, LIKE A SHORT OR SOMETHING¿ AND IT "WASN'T WORKING". IT REPORTEDLY TOOK THE PATIENT 2.5-3 HOURS TO GET IT TO HALF CHARGE. ADDITIONALLY, THE DEVICE WOULD ONLY HOLD A CHARGE FOR A FEW DAYS AND THEN IT WENT DEAD. THE BATTERY SEEMED TO GET WARMER THAN THE PATIENT¿S PREVIOUS DEVICE WHEN CHARGING. THE REPORTER INDICATED THAT THE PATIENT¿S DEVICE CAUSED ¿SLIGHT PAIN¿ AT THE CHARGING SITE. THE PATIENT WAS CONCERNED IF THE BATTERY COULD ¿LEAK OR EXPLODE¿ IF IT WAS SHORTING OUT. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED TO MEET A MANUFACTURER¿S REPRESENTATIVE. IT WAS LATER REPORTED THAT WHEN THE PATIENT MET WITH A MANUFACTURER¿S REPRESENTATIVE, IT WAS DETERMINED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS WORKING NORMALLY. THE PATIENT¿S PROGRAMS WERE DRAINING THE BATTERY RAPIDLY. THE PATIENT WAS REPROGRAMMED AND IT SEEMED TO BE A BETTER FIT. DOCUMENT CONTAINED NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224077 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