BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4167540 · Received October 13, 2014

    Report

    Report Number
    3004209178-2014-19585
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Report Date
    September 22, 2014
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# VA08F3E, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A 'HUGE FALL' IN (B)(6) OF LAST YEAR AND AN X-RAY SHOWED THAT THERE WAS APPROXIMATE 1.5 MM (MILLIMETER) MOVEMENT OF THE LEAD. THE PATIENT FELL ON THE INS (STIMULATOR). THE PATIENT FELL IN (B)(6) OF THIS YEAR DUE TO NEUROPATHY IN HER FEET, X-RAY SHOWED 1.0-1.7 MM MOVEMENT OF THE LEAD. THE PATIENT FELL AGAIN THIS (B)(6) THOUGH NO MOVEMENT WAS NOTED ON THE X-RAY. THE PATIENT'S INCISION HURTS STARTING AROUND THAT FIRST FALL. WHEN THE PATIENT STAND THE INS WAS A LITTLE ABOVE THE INCISION, WHEN SHE SITS DOWN IT MOVES UP EVEN FURTHER. THE HEALTHCARE PROVIDER REPORTED THAT THE PATIENT HAS HAD A LACK OF EFFECT SINCE THE FIRST FALL APPROXIMATE. THE PATIENT HAS BEEN ON PROGRAM 4 SINCE AROUND THAT TIME (0 POSITIVE, 3 NEGATIVE).THE HEALTHCARE PROVIDER WAS UNABLE TO RUN IMPEDANCES AT HIGHER THAN 1 VOLTS. PATIENT¿S PROGRAMS WERE ALL AROUND .2 VOLTS WITH ONE AT 1.3 VOLTS. THE IMPEDANCES WERE REPEATING VALUES, BUT THAT WAS LIKELY BECAUSE OF THE LOW TESTING VOLTAGE. WHEN SHE RAN IMPEDANCES, STIMULATION WENT FROM THE INS THEN DOWN TO PATIENT¿S VAGINAL AREA. THE FOLLOWING PROGRAMS AND IMPEDANCES WERE NOTED AS C0 575; C1 547; C2 547; C3 556; 01 1077; 02 1111; 03 1111; 12 746; 13 1111; 23 1111. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION RECEIVED, SUPPLEMENTAL WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648303 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR