BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3006412 · Received March 15, 2013

    Report

    Report Number
    3004209178-2013-03786
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    February 28, 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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 3093-33, LOT# V596329, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOST OR STOLEN PATIENT DEVICE. THEY HAD NOT RECEIVED REPLACEMENT PROGRAMMER FOR THE PATIENT WHICH HAD BEEN REQUESTED. THE PROGRAMMER WAS STILL IN TRANSIT DUE TO CONFUSION ABOUT THE ADDRESS. THE PROGRAMMER WAS TO BE DELIVERED LATER THAT DAY. AN IMPEDANCE ISSUE WAS NOTED. THERE WAS A READING >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. AS PART OF A ROUTINE CHECK OF PATIENT COMING, THEY CHECKED IMPEDANCES AND FOUND PAIRS INVOLVING 02, 03 AND 23 WERE >4K. IT WAS RECOMMENDED INCREASING DEFAULT TEST VALUES AND RE-RUNNING TEST. WHEN THEY INCREASED VOLTAGE AND PW (PULSE WIDTH) AND THEN THESE VALUES DECREASED TO: 02, 03 AND 23 =3217 OHMS. PATIENT WAS PROGRAMMED TO 3+2- AND HAD NOT HAD ANY CHANGES TO HIS STIM THERAPY, COULD FEEL STIM AND WAS GETTING GOOD THERAPY. IMPEDANCE WAS ON THE HIGH SIDE FOR 23 PAIR. IT WAS LATER REPORTED THAT REGARDING THE PATIENT PROGRAMMER, THEY WERE UNABLE TO COMMUNICATE WITH INS ON A BRAND NEW PROGRAMMER THAT WAS SENT TO THE OFFICE THEY ATTEMPTED SEVERAL TIMES WITH ANTENNA, WITHOUT ANTENNA, AND THEN PATIENT HAD TAKEN HIS PANTS OFF TO ATTEMPT. THESE ATTEMPTS DID NOT RESOLVE THE ISSUE. THEY COULD READ INS WITH 8840 PRIOR TO CALLING. THEY WERE ASKED TO REINTERROGATE WITH 8840 AND BOND PATIENT PROGRAMMER. THE PATIENT ONLY HAD ONE PROGRAM AND DID'T NEED ADDITIONAL SO THEY EXITED. UPON EXITING THE SESSION THE PATIENT PROGRAMMER COMMUNICATED PROPERLY AND PROMPTLY WITH IMPLANTED INS. THIS ISSUE WAS RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108571 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1