BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3374440 · Received September 27, 2013

    Report

    Report Number
    3004209178-2013-17115
    Event Type
    Malfunction
    Date Received
    September 27, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 6, 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: 3888-45, LOT# V210550, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-45 LOT# V218118 SERIAL# IMPLANTED: 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# V069647V02, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPEDANCE CHECK WAS RUN AT 0.7V AND CONTACTS 8, 9, 10 AND 11 SHOWED GREATER THAN 10,000 OHMS. THE IMPEDANCE CHECK WAS RUN AGAIN AT 1.5V AND CONTACTS 8, 9, AND 10 SHOWED GREATER THAN 20,000 OHMS, AND CONTACT 11 SHOWED 15,000. THE REPORTER STATED THE PATIENT HAD NOT REPORTED THERAPY ISSUES AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491000 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 00079 YR