BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3123589 · Received May 22, 2013

    Report

    Report Number
    3004209178-2013-08020
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    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 NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD; PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3887-33, LOT# L79600, IMPLANTED: (B)(6) 2000, PRODUCT TYPE LEAD; PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REPLACEMENT OF A NORMAL END-OF-LIFE (EOL) BATTERY, IMPEDANCE TESTING SHOWED IMPEDANCES OF OVER 40,000 OHMS ON CIRCUITS 4-7. THE LEAD CONFIGURATION USING THE CLINICIAN PROGRAMMER WAS CHANGED TO 2X4 AND CHANGED ELECTRODES FROM 4-7 TO 8-11 AND IMPEDANCES WERE THEN REPORTED TO HAVE BEEN FINE. ON THE OTHER LEAD, WITH 0 AS A REFERENCE ON 0-3 THEY WERE GETTING 150 WITH 1 AND 2, AND OVER 4,000 ON 3. A CONNECTION ISSUE WAS SUSPECTED. IMPEDANCES WERE REPORTED TO HAVE BEEN ¿GOOD ON THE TABLE.¿ THE PATIENT WAS NOT GETTING STIMULATION, HOWEVER IT WAS CORRECTED AFTER CHANGING FROM 4-7. IT WAS LATER REPORTED THE HIGH IMPEDANCES RESOLVED ON THE 2ND LEAD BUT LOW IMPEDANCES STILL EXISTED ON THE 1ST LEAD. THE LOW IMPEDANCES WERE PROGRAMMED AROUND AND THE PATIENT WAS GETTING GOOD RELIEF. IT WAS UNKNOWN IF LOW IMPEDANCES ON THE FIRST LEAD EXISTED PRIOR TO REPLACEMENT AS THE PREVIOUS BATTERY WAS AT EOL. NO CAUSE OF ISSUE WAS DETERMINED. NO INTERVENTIONS WERE TAKEN OR PLANNED. THE PATIENT AND THE PHYSICIAN CHOSE TO LEAVE THE SYSTEM AS-IS SINCE THE PATIENT WAS GETTING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225938 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