BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1171360 · Received September 17, 2008

    Report

    Report Number
    3004209178-2008-05858
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IMPEDANCES WERE NOT CHECKED INTRA-OPERATIVELY DURING IMPLANTATION. POST-OPERATIVELY (TIME UNKNOWN), THE PATIENT RECEIVED NO STIMULATION SENSATION AND THEN SUDDENLY FELT A SHOCKING OR JOLTING SENSATION DURING PROGRAMMING. IMPEDANCE READINGS WERE >40000 OHMS ON ELECTRODE COMBINATIONS 0-3. THE MANUFACTURER REPRESENTATIVE WAITED TWO HOURS TO REPROGRAM THE PATIENT; ALL IMPEDENCES WERE NORMAL AT THAT TIME. THE PATIENT HAD GOOD STIMULATION AND THE ISSUES WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention EXTENSION: MODEL 37083| EXTENSION: MODEL 37083| PROGRAMMER: MODEL 37743| EXPLANTED:| LEAD: MODEL 3998| EXPLANTED:| EXPLANTED: