BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3002742 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03679
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# J0455247V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT REPORTED NO STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT EXPERIENCED A LOSS OF BLADDER CONTROL, "LEAKAGE." IT WAS STATED THAT THE PATIENT HAD A RETURN OF SYMPTOMS ON (B)(6) 2013 "ALL OF A SUDDEN, NOT GRADUALLY." IT WAS NOTED THAT THE PATIENT KEPT GETTING A POOR COMMUNICATION SCREEN. IT WAS STATED THAT THE PATIENT WAS UNABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT THE ANTENNA ATTACHED. THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104919 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR