BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2740586 · Received September 12, 2012

    Report

    Report Number
    3004209178-2012-08008
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Report Date
    August 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V011590, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POWER-ON-RESET (POR) CONDITION. THE PATIENT HAD A NEUROSTIMULATOR BATTERY REPLACEMENT THE DAY OF REPORT. IT WAS REPORTED THAT "THINGS WENT FINE" IN OPERATING ROOM AND IN RECOVERY PATIENT WAS SET WITH ONE PROGRAM. THE PATIENT TRIED TO MAKE AN ADJUSTMENT WHEN THEY GOT HOME AND GOT THE "CALL YOUR DOCTOR" SYMBOL WITH THE POR MESSAGE. THE MESSAGE WAS CLEARED WITH AN 8840 CLINICIAN PROGRAMMER IN THE OFFICE THE FOLLOWING MORNING, AND IT WAS REPORTED THAT "ALL WAS FINE AND NO OTHER ISSUES". IT WAS REPORTED THAT THE PATIENT WAS "DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1