BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1951990 · Received January 4, 2011

    Report

    Report Number
    3004209178-2011-00029
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. TRAINING IS IN PLACE. RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFO THAT DURING SURGERY WHEN THE SURGEON TRIED TO CONNECT THE LEAD WITH THE IPG, ELECTRODES 0-7 SHOWED IMPEDANCES OVER 10,000 OHMS. THEN THEY TRIED TO CONNECT ELECTRODES 8-15 WITH THE IPG BUT IMPEDANCES WERE ALSO OVER 10,00 OHMS. THE PHYSICIAN TRIED FIVE TIMES BUT THE IPG WAS NOT WORKING. A MEDTRONIC REP ALSO TRIED THE CONNECTIONS AND STILL THE IPG DID NOT WORK. THE IPG WAS REPLACED WITH A NEW ONE AND CHECKED WITH THE N'VISION CLINICIAN PROGRAMMER AND IT FUNCTIONED NORMALLY. NO INFO WAS PROVIDED AS TO WHY THE PATIENT NEEDED THIS SURGERY. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1