BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2591009 · Received May 29, 2012

    Report

    Report Number
    3004209178-2012-03788
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Report Date
    May 21, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3093-28, LOT# V855059, IMPLANTED: 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TRIED 3 OF HER 4 PROGRAMS BUT CONTINUED TO HAVE ISSUES WITH LOSS OF BOWEL CONTROL. THE PATIENT ALSO STATED THAT SHE DID NOT GET PROPER EDUCATION ON THE THERAPY. IT WAS NOTED THAT THE PATIENT'S 'NERVES WERE NOT NORMAL' ON HER RIGHT SIDE, AND SHE HAD TO GO THROUGH TWO TRIAL SURGERIES AS THE LEAD WAS ORIGINALLY PLACED ON THAT SIDE. WHEN A LEAD WAS PLACED ON THE OTHER SIDE SHE RECEIVED SOME EFFECT. THE PATIENT COULD NOT FEEL ANY STIMULATION SENSATION, AND IT WAS BELIEVED THAT THE DEVICE HAD BEEN INADVERTENTLY TURNED OFF, EITHER BY THE PATIENT OR DUE TO AIRPORT SECURITY. THE PATIENT WAS INSTRUCTED HOW TO TURN STIMULATION BACK ON AND ADJUSTED IT TO A COMFORTABLE LEVEL. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH A NEW HCP TO TRY TO REPROGRAM THE DEVICE TO HAVE BETTER THERAPEUTIC EFFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1