BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3830725 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09586
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC 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 NEU_UNKNOWN_LEAD; PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS FOR STIMULATOR SERIAL NUMBER (B)(4) REVEALS FUNCTIONALLY OKAY AND INSIFGNIFICANT ANOMALIES. A KNOWN GOOD LEAD WAS ABLE TO BE FULLY INSERTED INTO THE STIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALL WAS ABOUT A SURGICAL PROCEDURE. DIFFICULTY ENCOUNTERED WHILE ADVANCING LEAD. PRIOR TO CALLING, THE LEAD WAS REPLACED FOR SAME REASON (UNABLE TO FULLY INSERT LEAD INTO HEADER BLOCK). CALLER NOTED VISUAL OF HEADER BLOCK LOOKED NORMAL (NO OBSTRUCTIONS). RESISTANCE ENCOUNTERED AND UNABLE TO SEE THE BLUE TIP AT END OF CONNECTOR BLOCK. IT WAS RECOMMENDED SLIGHTLY ROTATING STIMULATOR BUT STILL UNABLE TO INSERT LEAD. REPLACED STIMULATOR AND PHYSICIAN NOTED IT WAS MUCH BETTER (INSERTION). IT WAS NOTED THAT THE PATIENT NEW IMPLANT WITH A STAGED TRIAL. IT WAS LATER REPORTED THAT THE CALLER WAS REPORTING A PRODUCT DEFECT STIMULATOR. CALLER INDICATED THE CONNECTION THAT ATTACHES TO LEAD IS FAULTY, AS THEY WERE NOT ABLE TO ADVANCE THE LEAD ALL THE WAY INTO THE HEADER BLOCK. IT WAS LATER REPORTED THAT THE CALLER STATES HE WAS INVOLVED WITH AN STIMULATOR PLACEMENT WHERE THEY HAD TO OPEN A SECOND STIMULATOR. ((B)(4) IS THE DEVICE THAT IS BEING SENT BACK). 2014 (B)(6) RP (REP): ADDITIONAL INFORMATION REPORTS A POTENTIAL PERFORMANCE ISSUE. THE INTERSTIM LEAD WOULD NOT THREAD ALL THE WAY DOWN INTO THE STIMULATOR. IT WAS NOTED THAT THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308100 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1