BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4856293 · Received June 19, 2015

    Report

    Report Number
    3004209178-2015-11918
    Event Type
    Injury
    Date Received
    June 19, 2015
    Report Date
    June 1, 2015
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V926179, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (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 AND WAS NOT ABLE TO MAKE ADJUSTMENT BOTH WITH AND WITHOUT THE ANTENNA ATTACHED. THE PATIENT WAS TRYING TO INCREASE STIMULATION, BUT THE THERAPY ¿DIDN¿T SEEM TO BE WORKING LATELY.¿ THE PATIENT HAD URINARY RETENTION AND PAIN ¿EVERYWHERE ON HER BODY.¿ THE PATIENT HAD ARTHRITIS, AND POSSIBLY FIBROMYALGIA AS WELL AS HER BODY AND MUSCLES ACHED ALL OVER. FOLLOW-UP IS BEING CONDUCTED TO DETERMINE CAUSE, ACTIONS, AND OUTCOME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT IN RESPONSE TO FOLLOW-UP REPORTED THAT THEY HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE (REP) AND THEIR CONCERNS WERE RESOLVED. IT WAS ALSO STATED THAT THEY WERE STILL HAVING CONCERNS BUT WERE WORKING WITH THEIR DOCTOR OR REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401060 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other