BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3265172 · Received August 5, 2013

    Report

    Report Number
    3004209178-2013-12792
    Event Type
    Malfunction
    Date Received
    August 5, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V906470, 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 THAT THE PATIENT STILL FELT THE SENSATION IN ALL THREE PROGRAMS, BUT WAS NOT HAVING THE TYPE OF SUCCESS SHE DID IN THE PAST. THERE IS NO KNOWN ACCIDENT/INCIDENT RELATED TO THIS; ALTHOUGH, THE PATIENT HAD RECENTLY ROAD THE RIDES AT DISNEYLAND. AN IMPEDANCE CHECK REVEALED GREATER THAN 4000 OHMS ON SOME BIPOLAR PAIRS, 02 AND 03, AS WELL AS A REPEATING VALUE. THE IMPEDANCE TEST WAS RE-RUN AT 2.0 V, 270 PW, WITH THE FOLLOWING VALUES: C0=2213 OHMS, C1=1111 OHMS, C2=1111 OHMS, C3=1111 OHMS, 01=2085 OHMS, 02= >4000 OHMS, 03=> 4000 OHMS, 12=1111 OHMS, 13=1147 OHMS, AND 23=1111 OHMS. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO KNOWN CAUSE FOR THE EVENT, AND THE PATIENT WAS SET ON NEW PROGRAMS WHERE SHE FELT THE STIMULATION VAGINALLY. THE PATIENT WAS GOING TO TRY THESE NEW PROGRAMS TO SEE IF IT GETS BETTER AND IT WAS NOTED THAT NOTHING HAD BEEN EXPLANTED. 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
    365262 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR