BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2895432 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00120
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 10, 2012
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V161124, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GETTING A PAIN IN THEIR TAILBONE AREA. THIS PAIN BEGAN 2-3 DAYS PREVIOUS, BUT HAD BEEN GETTING WORSE IN THE LAST 24 HOURS. A LOSS OF THERAPEUTIC EFFECT WAS ALSO REPORTED AND THAT THERAPY WAS "NOT HELPING AS WELL AS IT WAS." IT WAS STATED THE PATIENT TRIED FOUR DIFFERENT PROGRAMS AT DIFFERENT AMPLITUDES, BUT THE PATIENT WAS STILL GETTING PAIN IN THE TAILBONE AREA. IT WAS NOTED THE PATIENT TURNED OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND COULD STILL FEEL STIMULATION AND THE PAIN THE TAILBONE. WHEN STIMULATION WAS TURNED UP ON PROGRAM 4, IT WAS STATED THE PATIENT COULD "FEEL THEIR FOOT DRAW" AND THIS INDICATED THE STIMULATION WAS ON. IT WAS FURTHER REPORTED THE PATIENT HAD A PREVIOUS INJURY TO THEIR TAILBONE AND THEY HAD URINARY RETENTION FROM A FALL. IT WAS ADDITIONALLY REPORTED THE SAME DAY, THE PATIENT COULD NOT TURN THE INS OFF AND IT WAS CAUSING THEM PAIN. IT WAS UNCLEAR IF AND WHEN THE INS COULD BE TURNED OFF. IT WAS NOTED THE PATIENT WOULD TRY TO SET UP AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER AND WOULD REQUEST A MANUFACTURER REPRESENTATIVE TO BE PRESENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1