BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4090352 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17050
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 20, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID NEU_RECHARGER_ACC, SERIAL # UNKNOWN, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PROGRAMMER (PP) WASN¿T WORKING AND WAS SHOWING A POOR COMMUNICATION SCREEN. THE PP WOULD NOT COMMUNICATE WITH THE INS, NOR COULD IT MAKE ADJUSTMENTS WHETHER THE ANTENNA WAS ATTACHED OR NOT. THE PATIENT HAD USED THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) TO CHECK IF THE STIMULATION WAS ON, WHICH IT WAS, BUT THE PATIENT WAS UNABLE TO FEEL ANY STIMULATION. THE PATIENT HAD STOPPED FEELING STIMULATION AFTER HAVING AN ¿ADJUSTMENT¿ DONE ON THE WEEK PRIOR TO THIS REPORT. DURING THE ADJUSTMENT, IT HAD BEEN WORKING FINE, BUT ONCE THE PATIENT HAD LEFT, THE BATTERY WAS ALMOST DEAD. ONCE THE PATIENT HAD LEFT, THE PATIENT ¿CHARGED IT UP AND THE NEXT DAY OR EVEN THAT AFTERNOON, [THE PATIENT] WAS TRYING TO TURN IT ON AND IT HADN¿T BEEN ON SINCE SHE PROGRAMMED IT.¿ THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. 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
    568506 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR