BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3085483 · Received April 30, 2013

    Report

    Report Number
    3004209178-2013-07066
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3093-28 LOT# V161901, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED: "NOT WORKING" AND THAT THE PATIENT HAD YET TO MAKE AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER.

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE PHYSICIAN REPORTED THAT THEY WERE NOT AWARE OF ANY ADVERSE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FOUND IT WAS FURTHER REPORTED THE CALLER SAW THE POOR COMMUNICATION SCREEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD A POR (POWER ON RESET) CONDITION. THE MESSAGE WAS JUST NOTICED TODAY, BUT IT WAS UNCERTAIN WHEN IT APPEARED AS THE PATIENT HAD NOT USED HER PROGRAMMER IN ABOUT SIX WEEKS OR SO. IT WAS NOTED THAT PATIENT WAS IN A HOSPITAL SETTING BACK IN (B)(6) FOR A CT SCAN OF HER SHOULDER FOR AN INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186231 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR