BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3053530 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06040
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 22, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# VA01JEF, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING FECAL ACCIDENTS. THE PATIENT REPORTEDLY HAD NOT CHANGED HER PROGRAMS OR ADJUSTED STIMULATION. THE PATIENT DID NOT FULLY UNDERSTAND PROGRAMMING AND HAD BEEN ON ONE SETTING. IT WAS ALSO STATED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS ALSO STATED THAT THE PROGRAMMER WOULD NOT TURN ON. THE PATIENT HAD NOT REPLACED THE PROGRAMMER BATTERIES AND HAD NOT USED THE PROGRAMMER IN 6 MONTHS. THE PATIENT DID NOT HAVE REPLACEMENT BATTERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ASSISTED IN ADJUSTING STIMULATION HIGHER AFTER HAVING BRIEF COMMUNICATION ISSUES WITH THE DEVICE. THE PATIENT ALSO STATED THAT SHE NEVER HAD TOTAL RELIEF FROM THE THERAPY. THE PATIENT STILL HAD ACCIDENTS AND WANTED TO KNOW WHY THEY DID NOT GO AWAY. THE PATIENT HAD ACCIDENTS FOR A DAY OR TWO, SOMETIMES MORE. THE PATIENT HAD AN ACCIDENT ON THE FRIDAY BEFORE THE REPORT THROUGH THAT SUNDAY AND HAD AN ACCIDENT THE DAY PRIOR TO AND DAY OF THE REPORT. THE PATIENT ALSO REPORTED HAVING A FALL ONE TO TWO MONTHS PRIOR TO THE REPORT. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. 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 THE PATIENT WAS STILL HAVING ACCIDENTS "ON AND OFF," INCLUDING A "MISHAP" TWO WEEKS PRIOR WHICH WAS "VERY EMBARRASSING." STIMULATION WAS INCREASED TO 5.5V WHERE THE PATIENT WAS FEELING STIMULATION COMFORTABLY. IT WAS STATED THE PATIENT WOULD MAKE AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER IF THEIR SYMPTOMS DID NOT IMPROVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT SINCE IMPLANT THE PATIENT HAD BEEN HAVING ACCIDENTS. THE PATIENT WANTED HELP CHANGING PROGRAMS. IT WAS NOTED THE PATIENT HAD USED THE PROGRAMMER A "LONG TIME AGO." AT THE TIME OF THE CALL, IT WAS DETERMINED THE DEVICE WAS OFF. IT WAS STATED THAT THE PATIENT NEVER TURNED THE DEVICE OFF. WITH ASSISTANCE, THE PATIENT WAS ABLE TO TURN THE DEVICE ON AND WAS FEELING STIMULATION. THE PATIENT CHANGED FROM PROGRAM 1 TO PROGRAM 3 AND INCREASED STIMULATION TO 3.5V. STIMULATION WAS REPORTEDLY NOT COMFORTABLE. IT WAS NOTED THAT STIMULATION WAS INCREASED TO 4.0V AND THE STIMULATION WAS "VERY FAINT." BY THE END OF THE CALL, STIMULATION WAS SET TO 4.1V AND THE PATIENT WAS GOING TO TRY THAT SETTING. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154931 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR