BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3443310 · Received November 1, 2013

    Report

    Report Number
    3004209178-2013-20049
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Report Date
    October 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V796194, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. NO STIMULATION SENSATION WAS NOTED. THERE WAS AN ISSUE REGARDING IMPEDANCE. THERE WAS READING >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. THE PATIENT HAD BEEN HAVING INCREASED LEAKING AND NOT FEELING STIMULATION FOR THE PAST 3 WEEKS. NO REPORTING OF FALL, TRAUMA OR ANY MEDICAL PROCEDURE DONE. DEFAULT ELECTRODE IMPEDANCE TESTED AT 1V/210PW: C0: 1160 OHMS C1: 1087 OHMS C2 :1087 OHMS C3 : 535 OHMS 01: >4K OHMS 02: >4K OHMS 03: 1450 OHMS 12: 1122 OHMS 13: 1122 OHMS 23: 1087 OHMS RETEST ELECTRODE IMPEDANCE AT 1.5V/300PW: C0: 1160 OHMS C1: 1067 OHMS C2: 1087 OHMS C3: 535 OHMS 01: >4K OHMS 02: >4K OHMS 03: 1450 OHMS 12: 1122 OHMS 13: 1122 OHMS 23: 1087 OHMS THE PATIENT WAS PROGRAMMED ON PROGRAM 2 AT 5.8V AND WAS NOT FEELING ANY STIMULATION AND CONTINUED TO HAVE LEAKAGE FOR THE PAST 3 WEEKS. INS BATTERY LONGEVITY ESTIMATED AT 9-16 MONTHS REPROGRAMMING DONE 210PW/14HZ C+3-: 6.5V: NO STIM PROGRAM 1. 3-0+: 3.0V COMFORT IN PERINEUM AREA. PROGRAM 2. 2-3+ 3.0V COMFORT IN PERINEUM AREA. PROGRAM 3. 1-3+ 4.1V COMFORT IN PERINEUM AREA C+1- 4.5V NOTHING. 5.1V COMFORT IN PERINEUM AREA. PROGRAM 4. C+2- 3.5V COMFORT IN PERINEUM AREA. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564425 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR