BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3832799 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09617
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 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 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME ELECTRODES HAD IMPEDANCES GREATER THAN 3600 OHMS. IT WAS NOTED THAT ONLY CONTACTS 0 AND 6 HAD IMPEDANCES GREATER THAN 3600 OHMS. IT WAS NOTED THAT OTHER CONTACTS WERE BETWEEN 579 AND 842 OHMS. THE REPORTER STATED THEY NOTICED THE HIGH IMPEDANCES TODAY AFTER RUNNING AN IMPEDANCE TEST. IT WAS NOTED THAT THERE WERE NO THERAPY ISSUES AND THE PATIENT WAS DOING GOOD. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE WAS ¿FINE TUNING¿ THE PATIENT¿S PROGRAMMING TODAY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO MALFUNCTIONS WERE SEEN AND NO INTERVENTIONS WERE PLANNED OR TAKEN. IT WAS NOTED THE PATIENT WENT THROUGH THE REPROGRAMMING SESSION AND WAS GETTING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310776 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR