BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2566841 · Received May 9, 2012

    Report

    Report Number
    3004209178-2012-03143
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Report Date
    April 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT # V851923, IMPLANTED: (B)(6) 2012, EXPLANTED: NA, PRODUCT TYPE LEAD. PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWED BY A SHOCKING SENSATION. THE PATIENT EXPERIENCED SIGNIFICANT LEAKING STARTING AROUND (B)(6) 2012. THEY STILL FELT STIMULATION OVER THE BUTTOCK WHEN USING PROGRAM 2 AT 3.5 V. THE PATIENT SWITCHED TO PROGRAM 4 AT 4.2 V TO SEE IF SYMPTOMS WOULD IMPROVE. ON (B)(6) 2012, THE PATIENT REPORTED A SHOCKING SENSATION AND A "SHARP PAIN AND GRIPPING SENSATION" ON THE BUTTOCK AREA THAT WAS "MORE THAN THEY COULD STAND." THE PATIENT WAS USING PROGRAM 1 AT 1.5 V BECAUSE THEY COULDN'T STAND PROGRAM 4 AT ALL. THERE WAS NO LEAKING, BUT THEY STILL EXPERIENCED SEVERE PAIN AND HAD DIFFICULTY WALKING. ALL OTHER PROGRAMS HAD BEEN TRIED BY THE PATIENT PREVIOUSLY. ON (B)(6) 2012, THE PATIENT REPORTED THEY HAD NO CONCERNS REGARDING THEIR THERAPY "AT THIS TIME" AND HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR ON (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1