BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3120379 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07897
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 29, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3889-28, LOT# V293834, IMPLANTED: (B)(6) 2009, 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 WHEN THE PATIENT SLEPT ON THEIR LEFT SIDE THERE WAS TOO MUCH STIMULATION IN THEIR LUNGS UNTIL IT FADED BUT IT DIDN'T FADE TOO MUCH. IT WAS NOTED THAT THE PATIENT WAS ABLE TO FEEL THEIR NEUROSTIMULATOR WITH THEIR HAND AND BEFORE THEY DID NOT FEEL IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED TO HAVE BEEN WORKING, BUT SYMPTOMS AND PAIN WERE RETURNING. THE SPECIFIC DATES WERE UNKNOWN. IT WAS NOTED THE PATIENT FELL ON (B)(6) 2013. THE PATIENT DID NOTICE SOME DIFFERENCES IN FREQUENCY AND THAT IT MAY BE DUE TO HOW MUCH THEY DRINK. THE IMPLANTABLE NEUROSTIMULATOR WAS FELT TO BE IN THE SAME AREA. 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
    222464 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1