BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3844893 · Received June 3, 2014

    Report

    Report Number
    3004209178-2014-10011
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS CHARGING YESTERDAY THEY NOTICED A THERMOMETER APPEAR ON THE RECHARGER SCREEN. IT WAS NOTED THE PATIENT HAD GONE MAYBE 30 HOURS OR A 1.5 DAYS WITHOUT STIMULATION. IT WAS FURTHER NOTED THE PATIENT HAD GONE A DAY WITHOUT STIMULATION BEFORE AND IT WAS FINE. THE REPORTER STATED THAT WAS NOT THE CASE TODAY. THE REPORTER FURTHER STATED THEY NORMALLY CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) WHEN NEEDED. IT WAS NOTED THE PATIENT STATED THEY WERE TOLD BEFORE THAT THEY WOULD HAVE TO GO AT LEAST TWO DAYS WITHOUT STIMULATION BEFORE THERE WOULD BE A PROBLEM. IT WAS FURTHER NOTED THAT NORMALLY WHEN THE PATIENT CHARGED THEY GOT A SCREEN THAT SAID THE INS WAS FULLY CHARGED. THE REPORTER STATED THE INS SHOWED TEAR DROPS COMING OUT. THE REPORTER FURTHER STATED THIS TIME THEY HAD A PICTURE OF THE INS WITH THE WATER WORKS AND THE THERMOMETER. IT WAS NOTED THE PATIENT DID NOT HAVE A FOLLOW UP HEALTHCARE PROFESSIONAL AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325231 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 00065 YR