BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2920762 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00723
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 28, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-33, LOT# V163870, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR REP RESENTATIVE. IT WAS NOTED THERE WAS AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. FOLLOW UP FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THE CAUSE OF THE EVENT WAS URINARY TRACT INFECTIONS AND SEVERE INCONTINENCE. IT WAS NOTED CYSTO REVEALED A BLADDER STONE WHICH WAS SURGICALLY REMOVED (B)(6) 2012. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS ALSO NOTED THE PATIENT HAD NOT FOLLOWED UP WITH THE HCP SINCE THE BLADDER STONE SURGERY. THE HCP DID NOT KNOW HOW THE PATIENT WAS DOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. PATIENT SYMPTOMS INCLUDE LOSS OF BLADDER CONTROL. IT WAS NOTED THE PATIENT HAD BEEN 'ESPECIALLY INCONTINENT.' IT WAS NOTED SYMPTOMS STARTED AFTER THE PATIENT FELL. THE PATIENT FELL RIGHT ON THE IMPLANTABLE NEUROSTIMULATOR (INS) AND HAD A LARGE BRUISE AND CUT. IT WAS NOTED THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE HEALTH CARE PROVIDER (HCP) IN THE EMERGENCY ROOM 'DID NOT KNOW MUCH ABOUT THE DEVICE' SO THE DEVICE WAS NOT CHECKED. PATIENT WAS ON PROGRAM 2 AT 1.05 VOLTS AND STIMULATION WAS ON. IT WAS NOTED WHEN THE PATIENT INCREASED STIMULATION TO 1.1 VOLTS THEY COULD FEEL STIMULATION, HOWEVER AFTER A FEW MINUTES THE PATIENT NO LONGER FELT STIMULATION. THE PATIENT BELIEVED THE STIMULATION WAS ACTING 'ERRATIC.' THE PATIENT HAD AN APPOINTMENT SCHEDULED (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25950 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention