BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6152582 · Received December 7, 2016

    Report

    Report Number
    3004209178-2016-25368
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 9, 2016
    Report Date
    December 28, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT REPORTED THE FIRST NIGHT THEY HAD ONE ACCIDENT AND THE NEXT DAY WAS BETTER AND THE NIGHT PREVIOUS TO THE CALL SHE WET HERSELF 4 TIMES AT NIGHT. THE PATIENT ALSO NOTED SHE WAS RECOVERING FROM FOOT SURGERY WHICH SHE HAD ABOUT 6 WEEKS AGO SO SHE CAN'T PLACE ANY PRESSURE ON ONE OF HER FEET AND THAT AFFECTED HER ABILITY TO WALK. THE PATIENT STATED SHE DID INCREASE THE SETTING BY ONE LAST THE NIGHT PREVIOUS TO THE CALL AS SHE WAS NOT FEELING STIMULATION AND NOW WHEN SHE WALKED IT WAS UNCOMFORTABLE IN THE CROTCH AREA. THE PATIENT VERIFIED THAT STIMULATION WAS ON AND THEY FELT STIMULATION. THE PATIENT STATED SHE CALLED THE HEALTHCARE PROFESSIONAL¿S (HCP) OFFICE AND THE HCP TOLD HER TO CALL THE MANUFACTURER AND POSSIBLY SWITCH PROGRAMS. THE PATIENT PLANNED TO MONITOR SYMPTOM CONTROL THE EVENING OF THE CALL AND IF SHE DIDN'T NOTICE ANY IMPROVEMENT SHE COULD ADJUST THE SETTING AGAIN THE NEXT DAY, HOWEVER NOT BEYOND HER COMFORT LEVEL. THE PATIENT PLANNED TO CALL IF SHE DECIDED TO SWITCH TO A DIFFERENT PROGRAM. THE PATIENT NOTED THEY HAD AN APPOINTMENT ON (B)(6). THE PATIENT REPORTED ON (B)(6) THEY RECEIVED THE IMPLANT AND HAD AN ACCIDENT THAT EVENING. ON (B)(6) SHE HAD 4 ACCIDENTS AND INCREASED SETTING AND SAID THAT STIMULATION WAS UNCOMFORTABLE WHEN SHE WALKED. THE PATIENT IS IMPLANTED FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM PATIENT REPORTED THAT THE ISSUE WITH ACCIDENTS AND UNCOMFORTABLE STIM HAD NOT BEEN RESOLVED. THE PATIENT TURNED STIM DOWN DURING THE DAY AND TURNED STIM UP WHEN GO TO BED. IT WAS NOTED THAT SHE HAD PAIN IN LOWER PART OF AREA WHEN WALKING. SHE DID NOT HAVE ACCIDENT WHEN TURNED UP AT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802924 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR