BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2251138 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07545
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT ENCOUNTERED AN OUT OF REGULATION (OOR) CONDITION WHEN ATTEMPTING THE STIMULATION. BUT, THE OOR CONDITION WAS NOT REPEATED WHEN THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS INTERROGATED BY THE HEALTHCARE PROVIDER (HCP). IMPEDANCE READINGS WERE GREATER THAN 10,000 OHMS ON ELECTRODE 0 AND 2. THE IMPEDANCE TEST WAS RUN AGAIN AFTER THE AMPLITUDE WAS INCREASED TO 3.0 VOLTS. IMPEDANCE READINGS WERE, THEN, BETWEEN 11,726 OHMS AND 19,637 OHMS FOR ELECTRODE 0. THE PT WAS PROGRAMMED AT 3+, 4+, 5-, 2.1 VOLTS, 510 PULSE WIDTH, AND 40 HZ. THE GROUP IMPEDANCE WAS 993 OHMS. THE PT DID NOT HAVE ANY ISSUES WITH STIMULATION OR COVERAGE. IT WAS LATER REPORTED THAT THE PT EXPERIENCED INTERMITTENT STIMULATION. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADD'L INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR PROGRAMMER: MODEL 37743, LOT# NKE155975N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB083122V| EXPLANTED:| LEAD: MODEL 3777, LOT# V287713003| ACCESSORY: MODEL 37752, LOT# NKA144987N| IMPLANTED: