BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4170581 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02971
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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 MEDICAL PRODUCTS: PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DUE TO HAVE HER IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED ON (B)(6), BUT THE DAY PRIOR, HER LEGS ¿WENT OFF¿ WHEN TRYING TO RECHARGE WHILE DRIVING. TODAY SHE WAS SEEING THE DOCTOR AND POWER ON RESET (POR) ON HER IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR). IT HAD BEEN TRYING TO GO OUT FOR QUITE SOME TIME, AT LEAST A WEEK AND IT HAD BEEN GIVING HER ISSUES STARTING ABOUT 6 MONTHS AGO. SHE HAD BEEN TO THE HEALTHCARE PROVIDER (HCP) AND THEY WERE TALKING ABOUT REPLACING IT. IT WAS TIME FOR IT TO GO OUT BECAUSE SHE HAD IT FOR 6 YEARS. THE PATIENT WAS ALSO NOT ABLE TO ADJUST STIMULATION AND A LOSS OF THERAPEUTIC EFFECT. THE PATIENT TRIED TO RECHARGE AND SAW THE POR AGAIN ON THE INSR. THE PATIENT WAS ADVISED ON HOW TO CLEAR IT AND SAID HER INSR WAS NOW WORKING. THE PATIENT WAS THEN ABLE TO GET HER EQUIPMENT WORKING AGAIN. 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
    650753 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712

    Patients

    Seq Age Sex Outcome Treatment
    1