BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4112249 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17604
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 3, 2014
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# VA02N68, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER VIA A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT¿S DEVICE WASN¿T WORKING. THE PATIENT HAD AN MRI IN THE PAST. THE HCP DIDN¿T KNOW WHY IT WASN¿T WORKING OR WHY THE PATIENT HAD THE MRI DONE IN THE PAST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS THE PATIENT'S 2ND IMPLANT. THE PATIENT HAD SUCH A GOOD EXPERIENCE WITH THE 1ST ONE , IT WENT ON ITS MERRY WAY UNTIL THE BATTERY WENT DEAD. THE PATIENT HAD A SUSPICION THAT HER THERAPY WAS NOT WORKING BUT THE PATIENT DID NOT EVEN KNOW IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON. THE PATIENT HAD FALLEN A MONTH OR TWO AGO, AND THE PATIENT WAS NOT SURE IF THAT SHUT OFF HER INS. THE PATIENT WAS WONDERING HOW TO TELL IF HER INS IS ON? REGARDING IF THE PATIENT WAS FEELING STIMULATION, THE PATIENT STATED SHE DOES NOT EVER FEEL STIM. REGARDING HOW SYMPTOMS WERE DOING, THE PATIENT STATED IN LAST WEEK OR TWO THEY HAD BEEN LEAKING. THE PATIENT TRIED THE PROGRAMMER AND TRIED SYNCHING WHILE ON THE PHONE. THE PATIENT WAS ON PROGRAM 2 AT 2.7. THE INS ICON LOOKED EMPTY. THE PATIENT WAS ASKED TO PRESS THE INS BUTTON. THE PATIENT INCREASED TO 2.9. (THE PATIENT SEEMED UNSURE IF SHE WAS SEEING THE LIGHTENING BOLT BUT THE PATIENT WAS ABLE TO INCREASE SO THE PATIENT HAD INS ON.) THE PATIENT ASKED IF HER SETTING WAS HIGH. IT WAS NOTED THAT THE PATIENT WAS SEEN IN SPRING OF 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A LOSS OR CHANGE OF THERAPY. NEITHER THERAPY FOR THE PATIENT'S BOWEL OR URINARY ISSUES HAD BEEN RELIEVED SINCE HAVING THEIR SECOND IMPLANT. THE PATIENT WAS TAKING MYTEGRA ORALLY AND SINCE THE DOES HAD BEEN DOUBLED, IT WAS HELPING. THE PATIENT HAD TRIED TO GET THEIR DEVICE TO WORK AND WAS FINDING IT DIFFICULT WITH THE INSTRUCTIONS. THE PATIENT NEVER FELT STIMULATION AND THE THERAPY WAS NOT ON. THE PATIENT TURNED IT ON AND THE ISSUE WAS NOT RESOLVED. THE PATIENT WANTED HELP SWITCHING TO A DIFFERENT PROGRAM, BUT IT WAS IMPOSSIBLE AS THE ANTENNA KEPT MOVING AND THE PATIENT COULDN'T HOLD STILL. THE PATIENT WOULD CALL BACK WHEN THEY HAD ASSISTANCE. THE NEXT DAY, THE PATIENT WAS ON PROGRAM 2 AT 3.20V AND SWITCHED TO PROGRAM 3 AT 3.10V WHERE THEY FELT STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592490 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR