BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1140624 · Received August 28, 2008

    Report

    Report Number
    3004209178-2008-05306
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL TWICE. A POWER ON RESET CONDITION OCCURRED. AN END OF SERVICE/END OF LIFE MESSAGE APPEARED. THE PATIENT'S HEALTHCARE PROVIDER DOES NOT HAVE IMPEDANCE MEASUREMENT RECORDS. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL 3889| EXPLANTED:| PROGRAMMER: MODEL 3037