BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3800887 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08768
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES OF >40000 OHMS WERE MEASURED ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). WHILE PERFORMING THE IMPEDANCE CHECK FOR AN UPCOMING MRI TODAY (AREA TO BE SCANNED: HEAD/BRAIN), IT WAS NOTED THAT ELECTRODES #11/12 SHOWED VALUES OF >20000 OHMS AT 1.5 VOLTS. AT 3.0 VOLTS, IMPEDANCES OF ELECTRODES 11-0 WAS 12432 OHMS, 12-0 WAS 32293 OHMS, AND 11-12 WAS >40000 OHMS. IT WAS NOTED THAT THE PATIENT HAD NOT USED THE INS FOR THE PAST 2 MONTHS (EXACT DATE UNKNOWN) AS WHEN THEY STARTED THEIR NEW MEDICATION ("PREDNOISE") IT HELPED WITH THEIR PAIN CONTROL. THE PATIENT WAS PROGRAMMED ON GROUP B, ON PROGRAM 1 (5+, 6-, 7+) AND PROGRAM 2 (11+, 12-, 13+). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT NO FURTHER DIAGNOSTICS WERE DONE. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. NO INTERVENTIONS WERE TAKEN OTHER THAN PROGRAMMING AROUND AFFECTED ELECTRODES. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277337 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 00056 YR