BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6080956 · Received November 7, 2016

    Report

    Report Number
    3004209178-2016-23299
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    January 1, 2016
    Report Date
    November 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT WAS IN A TREMENDOUS AMOUNT OF PAIN GOING FROM HER BACK TO THE BOTTOM OF HER FEET. THE PATIENT REPORTED THAT THE PAIN IS GETTING WORSE AND WAS CONSTANT. THE PATIENT ALSO REPORTED THAT THEY HAD A CAT SCAN DUE TO SWELLING IN THEIR STOMACH. THE PATIENT WAS UNSURE IF THE STOMACH SWELLING WAS RELATED TO THE INS OR THERAPY. THE PATIENT REPORTED THAT THEY THOUGHT THEY MIGHT NEED THE SYSTEM EXPLANTED, BUT WAS GOING TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER ABOUT IT. NO FALLS OR TRAUMAS WERE RELATED TO THIS ISSUE. THE ISSUE WAS NOT RELATED TO POSITIONAL MOVEMENT. TROUBLESHOOTING COULD NOT BE DONE DUE TO LACK OF ACCESS TO THE PRODUCT. THE PATIENT REPORTED THAT THEY DID NOT HAVE ACCESS TO THEIR PATIENT PROGRAMMER AND HAD NOT TRIED TO CHANGE ANY STIMULATION BECAUSE THEY HAD MOVED AND HAVE BEEN DEALING WITH THESE ISSUES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT AND IT WAS REPORTED THAT THE PAIN AND SWELLING ISSUES HAD NOT BEEN RESOLVED, BUT SHE WAS CURRENTLY FOLLOWING UP WITH THEIR HEALTHCARE PROVIDER AND WORKING ON TRYING TO RESOLVE THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734774 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR