BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3952465 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13408
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA0FMGA, IMPLANTED: (B)(6) 2014, 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 IMPEDANCES LESS THAN 250 OHMS. THE PATIENT HAD A NEW IMPLANT YESTERDAY WHERE THE MANUFACTURER REPRESENTATIVE WAS PRESENT. IT WAS NOTED THAT BIPOLE 0 AND 1 WAS LESS THAN 50 OHMS AND ALL OTHER COMBINATIONS WERE FINE. THE 0 AND 1 COMBINATION WAS PROVIDING STIMULATION WITH THE SCREENER BOX. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROVIDER (HCP) REMOVED THE LEAD AND DRIED IT OFF AND THEN REINSERTED IT WITH THE SAME RESULTS. THE MANUFACTURER REPRESENTATIVE INCREASED THE PULSE WIDTH TO 300 AND THE AMPLITUDE TO 3 AND AFTER RUNNING THE IMPEDANCE TEST AGAIN THEY GOT THE SAME RESULTS WITH LESS THAN 50 OHMS ON BIPOLE 1. IT WAS NOTED THAT POST-OPERATIVELY THEY PROGRAMMED ALL 4 PROGRAMS AROUND THAT ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430087 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR