BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4130287 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18014
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) SHOWED THE BATTERY LEVEL WAS DEPLETING QUICKLY ONCE IT WENT DOWN PAST ¾. UPON FURTHER CLARIFICATION THE PATIENT WAS ACTUALLY SEEING THE BATTERY DEPLETE QUICKLY ON THE PATIENT PROGRAMMER NOT THE INSR WHICH HAD BEEN HAPPENING FOR THE PAST TWO MONTHS TO SIX WEEKS. IT WAS DISCUSSED THAT THE PROGRAMMER SHOULD BE READING THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LEVEL FROM THE INS BUT IT WAS UNABLE TO BE CONFIRMED WHICH BATTERY ICON THE PATIENT REFERRING TO BUT PATIENT THOUGHT IT WAS THE ¿LEFT¿ ICON. 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
    607866 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