BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2193313 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05386
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED READINGS >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. ON (B)(6) 2011; AT 1.0V AND PW OF 180; 0-1, 0-2, 1-2, 1-3 WERE >4000. ON (B)(6) 2011; AT 1.0V AND PW OF 150: C-0, 0-1, 0-2, 1-2, 1-3 AND 2-3 WERE >4000. AT 1.0V AND PW 300, THE IMPEDANCES WERE AS FOLLOWS: C-0= 1645, C-1= 1593, C-2= 1593, C-3= 801, 0-1= >4000, 0-2= <4000, 0-3=2124, 1-2= 3168, 1-3= 1758, 2-3= 1758. FOR ALL PROGRAMS THE PT WAS FEELING STIMULATION AND THEREFORE, NOT SUSPECTED THAT IT WAS A SYSTEM ISSUE. IT WAS REPORTED THAT THE PT THOUGHT THE DEVICE HAD STOPPED WORKING. ADD'L INFO 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
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR LEAD: MODEL 3389, LOT #V631583| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT #NJD123030N| IMPLANTED: