BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3182528 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10712
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 30, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# VA05W0Q, IMPLANTED: (B)(6) 2013, 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 THERAPEUTIC EFFECT AND STIMULATION WAS NOT ¿WORKING PROPERLY.¿ THE PATIENT HAD NO STIMULATION SENSATION AND HAD A LOSS OF BLADDER CONTROL. THE PATIENT STATED THAT HE WALKED THROUGH A METAL DETECTOR AND NOTICED ON (B)(6) 2013 THAT HIS STIMULATION WAS NOT WORKING PROPERLY. THE PATIENT ONLY FELT STIMULATION AT NIGHT WHEN LYING DOWN. THE PATIENT ALSO FELT IT ¿SOMETIMES¿ DURING THE DAY WHEN HE WAS RECLINED. THE PATIENT STATED THAT HIS STIMULATION USED TO COME ON ¿EVERY THIRTY SECONDS OR SO AND THEN SHUT OFF.¿ THE PATIENT DID NOT ¿REALLY FEEL MUCH OF THIS ANYMORE.¿ THE PATIENT TRIED INCREASING STIMULATION ¿ONE TENTH OF A POINT¿ AND STIMULATION WAS ¿MUCH TOO STRONG.¿ THE PATIENT TRIED LOOKING AT THE ¿BOOKS¿ BUT WAS CONFUSED ON WHAT TO DO NEXT. TROUBLESHOOTING REVEALED THAT THE PATIENT¿S DEVICE WAS OFF AND HE STATED THAT HE HAD BEEN ¿PUSHING BUTTONS SO MAY HAVE DONE THIS RECENTLY.¿ THE PATIENT HAD NOT SPOKEN WITH HIS HEALTH CARE PROVIDER (HCP) ABOUT THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE DIAMOND WITH THE QUESTION MARK ON THEIR PROGRAMMER SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282385 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1