BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2442622 · Received February 8, 2012

    Report

    Report Number
    3004209178-2012-00861
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    January 20, 2012
    Report Date
    January 20, 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

    LEAD: MODEL 3889, LOT# V802404, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6). LEAD: MODEL 3889-28, LOT# V802404, IMPLANTED: 2012 (B)(6), EXPLANTED: NA. PROGRAMMER: MODEL 3037, SERIAL# (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF LEAD MODEL # 3889-28, LOT # V802404, SHOWED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM FOR A LEAD REVISION. HER FIRST LEAD WAS REPLACED, BUT HIGH IMPEDANCES WERE SEEN ON THE SECOND LEAD, AND THE DECISION WAS MADE TO REPLACE HER NEUROSTIMULATOR (SEE MFR. REP. # 3004209178-2012-00860). WHEN THE NEW IMPLANTABLE NEUROSTIMULATOR (INS) WAS CONNECTED TO THE SECOND LEAD THE HIGH IMPEDANCES WERE STILL SEEN. THE DECISION WAS MADE TO REMOVE THE SECOND LEAD AND IMPLANT ANOTHER. THERE WERE NO ABNORMAL IMPEDANCES SEEN ON THE THIRD LEAD, AND IT WAS REPORTED THAT THE PATIENT WAS DOING GREAT FOLLOWING THE SURGERY.

    Description of Event or Problem · 1

    THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 54 YR