BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2191007 · Received July 19, 2011

    Report

    Report Number
    9614453-2011-05564
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    OUT OF RANGE IMPEDANCES WERE REPORTED. AN IMPEDANCE TEST ON THE LEAD SHOWED HIGH IMPEDANCES >10,000 ON ALL ELECTRODES. THE LEAD WAS CLEANED AND RECONNECTED, AND IMPEDANCES WERE THEN WITHIN NORMAL LIMITS. A POST-OP IMPEDANCE TEST SHOWED LOW IMPEDANCES (<50 OHMS) FOR ALL ELECTRODES ON THE LEAD EXCEPT ONE. THE ISSUE HAD NOT BEEN RESOLVED AND THE LEAD COULD NOT BE USED, HOWEVER, THE PT'S OTHER LEAD WAS PROVIDING SUFFICIENT COVERAGE. DURING IMPLANT, THERE WAS ALSO DIFFICULTY GETTING THE CLINICIAN PROGRAMMER TO COMMUNICATE WITH THE IMPLANTED NEUROSTIMULATOR. THE PT WAS NOT INJURED AND RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC EUROPE SARL 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| LEAD: MODEL 3878, LOT# 0204514053| EXPLANTED:| LEAD: MODEL 3878, LOT# 0204210404| IMPLANTED: