BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1133124 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05182
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE IMPEDANCE ON ELECTRODE 8 WAS 150 OHMS. THERE WAS NO TRAUMA ASSOCIATED WITH THE LOW IMPEDANCE READING. THE PATIENT HAD NO SHOCKING OR JOLTING SENSATION. THE PATIENT WAS RECEIVING GOOD STIMULATION, AND HAD NO FURTHER COMPLAINTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777| LEAD: MODEL 3777| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081| IMPLANTED: