BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4480020 · Received February 3, 2015

    Report

    Report Number
    3004209178-2015-01641
    Event Type
    Malfunction
    Date Received
    February 3, 2015
    Report Date
    January 14, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT # V000795, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LESS THAN 50% THERAPY RELIEF. AN IMPEDANCE ISSUE FOUND DURING AN IMPEDANCE TEST. THERE WERE HIGH IMPEDANCES FOR 4, 9, 10, AND 11 >20000. REPROGRAMMING WAS PERFORMED AROUND THE IMPEDANCE ISSUES AND THE PATIENT WAS ABLE TO GET GOOD COVERAGE AND WAS RECEIVING EFFECTIVE THERAPY. THE PATIENT WAS ALIVE WITH NO INJURY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77113 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