BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2840811 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10588
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 24, 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

    PRODUCT ID, 3093-28 LOT# VA02N68, PRODUCT TYPE LEAD PRODUCT ID, 3093-28 LOT# VA0 2N68, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH IMPEDANCES WAS SEEN DURING AN INTRA-OPERATIVE. THE IMPEDANCES WERE >4000 OHMS ON SOME OF THE BIPOLAR P AIRS. IMPEDANCES >4000 OHMS WAS ON ALL OR SOME UNIPOLAR PAIRS. AN IMPEDANCE TEST AT DEFAULT AND AT 2.0V/210 PW WAS PERFORMED. IMPEDANCE TESTS AT 2.0V/360 PW OR 3.0V/450 PW WERE PERFORMED. THE MANUFACTURER'S REPRESENTATIVE STATED THEY WERE GETTING GOOD MOTOR RESPONSE AT 0 DURING TESTING. A REVIEW SHOWED EVERYTHING WAS WORKING FINE BUT FOR SOME REASON THERE WAS AN ISSUE WITH 0 ELECTRODE. ALL OTHER VALUES WERE AROUND 1000 OHMS AND LOWEST WAS 600 OHMS. ADDITIONAL INFORMATION INDICATED THAT INCREASING THE IMPEDANCES AND PULSE WIDTHS DIDN'T WORK BECAUSE KEPT GETTING >4000 ON ALL THE 0 ELECTRODE COMBINATIONS. ANOTHER LEAD WAS USED AND EVERYTHING PASSED WITH NORMAL IMPEDANCES. THE PATIENT IS DOING FINE.

    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