BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3180467 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10651
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 29, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA080EE, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA080EE, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURING REPRESENTATIVE. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION ¿SEEMED TO GO OFF¿. THE PATIENT REPORTEDLY FELT NO STIMULATION SENSATION. THE REPORTER INDICATED THAT THE PATIENT INCREASED STIMULATION BY 0.1V BY THE SECOND WEEK IN MAY AND THE NIGHT PRIOR TO THE REPORT, INCREASED STIMULATION BY .2V BECAUSE SHE WASN¿T FEELING STIMULATION. THE PATIENT WAS INITIALLY INFORMED THAT SHE HAD TO FEEL STIMULATION ALL THE TIME. THE PATIENT REPORTEDLY SAW HER HEALTHCARE PROVIDER (HCP) ON (B)(6) 2013 AND IT WAS SHORTLY AFTER THAT APPOINTMENT THAT THE PATIENT STOPPED FEELING STIMULATION AND WENT BACK TO A ¿URINATING PATTERN¿ LIKE PRIOR TO IMPLANT. THE PATIENT COULDN¿T FEEL STIMULATION DURING THE DAY BUT COULD FEEL STIMULATION AT NIGHT WHILE LYING DOWN. THE REPORTER INDICATED THAT THE PATIENT COULD FEEL STIMULATION WHILE ¿LEANING UP AGAINST A WOODEN RAILING¿. THE NIGHT PRIOR TO THE REPORT, THE PATIENT FELT STIMULATION ¿ON THE LEFT SIDE OF HER VAGINA¿ WHEN SHE ¿LEANED ON BOTH HER LEFT AND RIGHT ELBOW¿. IT WAS NOTED THAT THE STIMULATION SENSATION FROM THE DEVICE WAS DIFFERENT THAN THE SENSATION THE PATIENT FELT DURING THE TRIAL. THE SENSATION FROM THE DEVICE WAS REPORTEDLY ¿MORE DELICATE¿. THE REPORTER INDICATED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH HER HEALTHCARE PROVIDER ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE ¿PULLING WAS SO INTENSE¿ THE NIGHT PRIOR TO THE REPORT THAT THE PATIENT COULD NOT LAY ON IT. THE DAY OF THE REPORT, THE PATIENT ¿COULDN¿T SIT DOWN¿ TO EAT BREAKFAST. FOR NO REASON, ¿IT WENT HIGHER¿. THE REPORTER HOWEVER CLARIFIED THAT THE NUMBER DID NOT GO ANY HIGHER AND WAS STILL SHOWING AS 3.3V. THE REPORTER INDICATED THAT THE PATIENT WAS OK WHEN WALKING BUT WHEN SHE ¿SAT DOWN IT WAS REALLY INTENSE¿. THE REPORTER STATED THAT THE PATIENT WANTED TO ¿MAKE SURE¿ BEFORE SHE ¿TOUCHED THE PROGRAMMER¿ TO INCREASE AND DECREASE STIMULATION¿. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280641 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1