BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3113409 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07682
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 24, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V941183, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF BLADDER CONTROL AND HER DEVICE WAS ¿TURNING OFF.¿ THE PATIENT HAD UNRELATED SURGERY ON (B)(6) 2013. THE NEXT DAY THE PATIENT TURNED THE DEVICE BACK ON. THE PATIENT NOTICED A RETURN OF SYMPTOMS WHEN SHE GOT HOME ON (B)(6) 2013 SO THE PATIENT USED THE PROGRAMMER TO CHECK THE DEVICE AND FOUND THAT IT WAS OFF EVEN THOUGH SHE HAD TURNED IT ON. THE PATIENT STATED THAT WHEN SHE ¿TURNED IT ON, IT SHOWED THAT IT WAS OFF AND SHE KNEW SHE TURNED IT ON,SO IT SHOULD HAVE SHOWN THAT IT WAS ON.¿ THE PATIENT CLARIFIED THAT BY ¿SHUTTING OFF¿ SHE REFERRED TO THE ¿LIGHT BULB BUTTON.¿ AT THE TIME OF THE REPORT THE PATIENT DID NOT FEEL STIMULATION BUT TURNED HER STIMULATION ON AND FELT IT. THE STIMULATION WAS IN THE RIGHT LOCATION AND HAD NOT MOVED. THE SETTINGS WERE THE SAME AS PRIOR TO SURGERY AND THE PATIENT DID NOT RECALL BEING AROUND ANY STRONG ELECTROMAGNETIC INTERFERENCE WHILE AT THE HOSPITAL. THE DEVICE WAS LAST CHECKED BY A HEALTH CARE PROVIDER (HCP) IN (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD TURNED THE DEVICE OFF FOR SURGERY ON (B)(6) 2015, BUT WHEN THE DEVICE WAS TURNED BACK ON, "SHE WAS HAVING PROBLEMS" WITH SYMPTOM RETURN. THE DEVICE WAS CONFIRMED TO BE ON, SO THE PATIENT INCREASED STIMULATION BUT THERE WAS NO CHANGE PERCEIVED IN SYMPTOMS. AFTER A WHILE, THE PATIENT COULD NOT FEEL STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214643 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR