BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3080384 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06960
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 8, 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 3999, PRODUCT TYPE LEAD; PRODUCT ID NEU_ADAPTOR_ACC, PRODUCT TYPE ACCESSORY; PRODUCT ID 3999, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECENTLY HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT AND WAS EXPERIENCING 'HIGH/ABNORMAL' IMPEDANCE VALUES. IT WAS NOTED THAT THE PORT 0-7 WAS THE CORRECT PORT AND PORT 8-15 WERE NOT BEING USED (EXPECTED OPENS, GREATER THAN 40,000 OHMS, SINCE NO LEAD WAS IN THAT PORT). IT WAS FOUND THAT ALL ELECTRODES HAD NORMAL IMPEDANCE MEASUREMENTS (TESTED AT 3.0 VOLTS) EXCEPT ELECTRODE 0 (IMPEDANCES BETWEEN 11,000 AND 20,000 OHMS), ELECTRODE 1 (IMPEDANCES BETWEEN 9,400 AND 16,000 OHMS), ELECTRODE 6 (ALL AROUND 5,000 OHMS), AND ELECTRODES 3 AND 4 HAD IMPEDANCES LESS THAN 150 OHMS (POSSIBLE SHORT). THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. IT WAS STATED THAT THE PATIENT WAS ABLE TO FEEL STIMULATION ON ELECTRODES 2, 3, 4, 5, AND 7. THE MANUFACTURER REPRESENTATIVE WOULD TRY TO REPROGRAM AROUND THE ABNORMAL IMPEDANCE VALUES. IT WAS LATER REPORTED THAT THE PATIENT HAD A LEAD THAT WAS NOT REGISTERED IN THE DEVICE REGISTRY AND IT WAS A 2X4 PADDLE LEAD. THE MANUFACTURER REPRESENTATIVE WAS ABLE TO MAKE THE APPROPRIATE ADJUSTMENTS AND THE PATIENT WAS ABLE TO FEEL EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182321 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1