BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3013589 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-04008
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    March 5, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V914060, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS ADDED THAT THE PATIENT HAD A LOSS OF BLADDER CONTROL. IT WAS STATED THAT THE PATIENT WOULD GET THE URGE TO URINATE, BUT THEN NOTHING WOULD COME OUT. IT WAS NOTED THAT THE PATIENT HAD 2 FALLS AT THE (B)(6) 2013. IT WAS STATED THAT SYMPTOMS STARTED TO RETURN ABOUT 1 AND A HALF AND 2 WEEKS PRIOR TO THIS REPORT. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THEIR HEALTHCARE PROVIDER. IT WAS STATED THAT THE PATIENT DID NOT FEEL STIMULATION AND DID NOT "FEEL PRESSURE." THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115629 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR