BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3143321 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08570
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 14, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 889-28, LOT# VA01W5V, 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 BEEN EXPERIENCING ¿REALLY BAD CRAMPING WHERE THE DEVICE WAS LOCATED¿ AND IT FELT LIKE ¿LABOR PAINS¿. THE PATIENT¿S CRAMPING WAS INDICATED TO HAVE FELT LIKE THE PATIENT¿S ¿OVARIAN CYSTS WERE POPPING¿, ALTHOUGH THE PATIENT ¿DIDN¿T THINK THAT WOULD LAST THAT LONG¿. THE PATIENT COULD REPORTEDLY FEEL THIS CRAMPING ¿AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE, ON HER LEFT HIP OR LOWER BACK AREA¿, AND COULD FEEL IT ¿FROM THE BACK TO THE FRONT¿. THE REPORTER INDICATED THAT ¿GOING TO THE BATHROOM HELPED A LITTLE BIT AND IT EASED UP¿. WHEN THE PATIENT LAY DOWN HOWEVER, THE CRAMPING RETURNED. THIS WAS NOTED TO HAVE STARTED ABOUT A WEEK PRIOR TO THE REPORT AND WAS OCCURRING ¿OFF AND ON¿ A COUPLE OF TIMES A DAY. THE REPORTER ALSO INDICATED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH SYMPTOMS OF ACUTE PAIN AND LOSS OF BLADDER CONTROL. THE PATIENT HAD ALSO REPORTEDLY BEEN HAVING PROBLEMS WITH LEAKAGE. IT WAS NOTED THAT THE PATIENT ¿DIDN¿T EXACTLY KNOW¿ WHEN THIS STARTED. HOWEVER, THIS WAS NOTED TO HAVE OCCURRED FOLLOWING EXPOSURE TO A THEFT DETECTOR OR SECURITY GATE AT A POLICE DEPARTMENT. ITWAS UNKNOWN IF THE DEVICE WAS ON DURING THE EXPOSURE. IT WAS NOTED THAT A WAND WAS USED WHEN THE PATIENT WENT THROUGH THE METAL DETECTORS WHICH OCCURRED ¿AROUND (B)(6) 2013¿. THERE WERE HOWEVER, NO CHANGES TO THE INS SITE. THE REPORTER INDICATED THAT SOMETIMES, THE PATIENT¿S SON ¿FORGOT THAT IT WAS THERE AND HIT HER THERE¿. IT WAS NOTED THAT ¿HE HIT HARD¿, BUT THE PATIENT DIDN¿T THINK ¿IT WAS HARD ENOUGH TO DO ANY DAMAGE¿. THE PATIENT ALSO REPORTEDLY HAD AN ¿ISSUE¿ WHERE SHE WENT 24 HOURS WITHOUT USING THE BATHROOM, BUT WENT TO THE EMERGENCY ROOM AND IT WAS DISCOVERED THAT THE PATIENT WAS DEHYDRATED. AT THE TIME OF THE REPORT, THE PATIENT¿S STIMULATION WAS OFF. THE PATIENT DID NOT KNOW STIMULATION WAS OFF AND DID NOT RECALL TURNING IT OFF. STIMULATION WAS TURNED ON AND THE PATIENT COULD NOT FEEL STIMULATION ON ¿GROUP 3¿. THE PATIENT COULD HOWEVER, FEEL STIMULATION COMFORTABLE IN HER BICYCLE SEAT AREA AT 0.95V ON PROGRAM 3. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION REVIEWED INDICATED THAT PATIENT WAS NOT FEELING STIMULATION WHILE DEVICE WAS TURNED ON AND FELT IT WHEN CHANGED TO PROGRAM 3. IT WAS ALSO NOTED THAT PATIENT DID NOT TURN THE STIMULATION OFF AND IT WAS NOTED OFF.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD NOT SCHEDULED AN APPOINTMENT WITH THEM FOR THE ISSUE AND MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244482 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1