BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2617617 · Received June 15, 2012

    Report

    Report Number
    3004209178-2012-04530
    Event Type
    Malfunction
    Date Received
    June 15, 2012
    Report Date
    May 18, 2012
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V973529, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A DECREASE IN THERAPEUTIC EFFECT. THE PATIENT REPORTED HER BLADDER GOT WORSE AND WAS LEAKING. UP UNTIL A DAY PRIOR TO THIS REPORT EVERYTHING WAS WORKING FINE. NO BODY TRAUMA OR FALLS COULD HAVE BEEN RELATED TO THE CHANGE IN SYMPTOMS. THE PATIENT CHANGED THE SETTING ON HER INTERNAL NEUROSTIMULATOR (INS) FROM PROGRAM 1@ 0.35 TO 0.4. PATIENT OUTCOME WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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