BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3070378 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06622
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 1, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V660709, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE TRIAL WORKED WONDERS BUT THE IMPLANT HADN'T HELPED AT ALL. THE PATIENT TRIED AT THE BEGINNING AND GOT TO A POINT WHERE IT WAS "ALL RIGHT" BUT IT HAD NEVER HELPED. THE HEALTHCARE PROVIDER WANTED TO DO AN MRI OF THE PATIENT'S BACK RELATED TO THE DEVICE. IT WAS NOTED THAT THE DEVICE HAD NEVER WORKED AND THE PATIENT WAS STILL RUNNING TO THE BATHROOM LIKE A "SUN OF A GUN". THE PHYSICIAN WANTED TO DO AN MRI TO SEE WHY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR AND THEIR CONCERNS WERE NOT RESOLVED. IT WAS STATED, THE DOCTOR COULD ¿NOT HELP ANY FURTHER.¿ IT AGAIN STATED, THE DEVICE ¿DID NOT WORK¿ AND IT WAS ¿NOT SUCCESSFUL.¿ IT WAS INDICATED THE PATIENT HAD NOT SOUGHT FURTHER HELP AFTER MEETING WITH THEIR DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172897 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1