BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2990148 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03332
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT # VA01HA5, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3031A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. THE PATIENT REPORTED PROBLEMS THAT WERE "FECAL AND URINARY IN NATURE." THE PATIENT ADDITIONALLY REPORTED "WEARING DIAPERS." IT WAS FURTHER REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) "WAS DEAD" AND "HADN'T WORKED FOR A COUPLE MONTHS." INTERROGATION OF THE INS WAS NOT POSSIBLE AT THE TIME OF REPORT AS THE PATIENT REPORTED HAVING "LOST HER PATIENT PROGRAMMER." IT WAS ADDITIONALLY REPORTED THAT HE PATIENT HAD "A KNEE REPLACEMENT" ON (B)(6) 2013 AND THAT "HER KNEE WAS SWOLLEN FROM KNEE SURGERY" AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. PATIENT HAD A LOSS OF BLADDER CONTROL. PATIENT ¿THINKS THEIR STIMULATOR STOPPED WORKING.¿ THE PATIENT IS NOT SURE IF IT IS BROKEN BUT THEY HAVE NO STIMULATION SENSATION. THE PATIENT HAD BEEN HAVING ISSUES WITH SYMPTOMS CONTROL SINCE (B)(6) 2013 AFTER THEY HAD A TOTAL KNEE REPLACEMENT. WHEN THE PATIENT WAS IN THE HOSPITAL THEY HAD NO BLADDER CONTROL. PATIENT TRIED MAKING ADJUSTMENTS BUT IT DID NOT HELP. THE PATIENT HAD TRIED CHANGING BATTERIES TO SEE IF IT WOULD HELP. THE PATIENT SAID THE PROGRAMMER CAME ON BUT THEY WERE NOT UNDERSTANDING THE SETTINGS. STIMULATION WAS CONFIRMED AS ON AND WHEN PATIENT INCREASED STIMULATION THEY SAID THEY WERE FEELING IT IN THEIR BIKE SEAT AREA. PATIENT NOTED THEY WERE NOT CURRENTLY KEEPING A VOIDING DIARY.

    Description of Event or Problem · 1

    IT HAD BEEN PREVIOUSLY REPORTED THAT THE PATENT WANTED TO TURN THE DEVICE ON BUT IT WAS ALREADY ON. THE PATIENT¿S AMPLITUDE WAS INCREASED FROM 3.2V TO 3.5V AND THE PATIENT COULD FEEL STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER HEALTHCARE PROVIDER (HCP) OR MANUFACTURER¿S REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. THE PATIENT WAS HOPING TO GET AN APPOINTMENT IN (B)(6). IT WAS ALSO INDICATED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING DEVICE OR THERAPY BUT WAS WORKING WITH HER HCP OR MANUFACTURER¿S REPRESENTATIVE. IT WAS UNCLEAR IF THE PATIENT STILL HAD CONCERNS AND WHETHER OR NOT SHE HAD SOUGHT FURTHER HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93354 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1