BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3296543 · Received August 19, 2013

    Report

    Report Number
    3004209178-2013-14838
    Event Type
    Malfunction
    Date Received
    August 19, 2013
    Date of Event
    July 2, 2013
    Report Date
    August 19, 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

    PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE CHECKS FOLLOWING A REVISION OF THE IMPLANTABLE NEUROSTIMULATOR (REFER TO MANUFACTURER REPORT #3004209 178-2013-12125) SHOWED THAT CONTACTS 10 AND 15 WERE OVER 10,000 OHMS. THE CONTACTS WERE NOT BEING USED FOR STIMULATION AND THE PATIENT WAS DOING WELL. THE PATIENT HAD GOOD RELIEF IN THE LEGS AND 50% RELIEF IN THE LOW BACK. THE HIGH IMPEDANCES WERE ORIGINALLY REPORTED IN THE REFERENCED MANUFACTURER REPORT NUMBER, HOWEVER, THE IMPEDANCES PERTAIN TO THE SYSTEM REPORTED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400499 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 00038 YR