BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6141256 · Received December 2, 2016

    Report

    Report Number
    3004209178-2016-25036
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    October 4, 2016
    Report Date
    January 10, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. 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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889-28 ,LOT# VA0GF3X , PRODUCT TYPE: LEAD.

    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 THEY DID NOT FEEL STIMULATION AND THEIR SYMPTOMS WERE NOT BEING CONTROLLED, SO THEY THINK THEIR IMPLANT HAS STOPPED WORKING. THE PATIENT STATED THEY GOT THE DEVICE FOR FECAL INCONTINENCE AND THEY ONLY TURNED STIMULATION UP WHEN THEY WERE DOING ACTIVITIES SUCH AS SWIMMING OR WALKING BECAUSE THEY ONLY HAD BOWEL INCONTINENCE WHEN THEY DID THOSE ACTIVITIES. THEY USUALLY FELT STIMULATION BY 3.0V. THE PATIENT HAD GONE FOR A LONG WALK AND COULD NOT FEEL THE STIMULATION WHEN THEY TURNED IT UP. THEY MENTIONED THEY HAD THEIR FIRST BOWEL INCONTINENCE EPISODE IN THE PAST AND NOW THEY WERE HAVING THEM AGAIN. THEY TRIED INCREASING STIMULATION TO 8.5V ON ALL 4 PROGRAMS AND THEY STILL COULD NOT FEEL STIMULATION. THE PATIENT FURTHER MENTIONED THAT THEY USUALLY FEEL STIMULATION BUT IT IS SO SUBTLE THAT ITS SOMETIMES HARD TO TELL. THEY WOULD FEEL IT 7 SECONDS ON AND THEN 7 SECONDS OFF. DURING THE REPORT THEY WERE ON PROGRAM 1 AT 1.4V. DURING THE REPORT, THEY INCREASED STIMULATION TO 8.5V ON PROGRAMS 1, 2 AND 3, AND THE PATIENT DID NOT FEEL STIMULATION. THEY DID NOT TRY PROGRAM 4. THEY TURNED STIMULATION BACK TO WHERE THEY THINK THEY ORIGINALLY SET IT BEFORE THEY MADE ANY CHANGES AND STATED THEY WOULD LEAVE IT THERE UNTIL THEY TALKED WITH THEIR HCP. THE RETURN OF SYMPTOMS WAS NOTED TO HAVE STARTED A MONTH PRIOR TO THE REPORT AND THEIR LOSS OF STIMULATION WAS IN THE LAST COUPLE OF DAYS WHEN THEY TRIED TO INCREASE STIMULATION UP HIGH AND COULD NOT FEEL IT. THEY WERE NOT SURE WHEN THEY HAD STOPPED FEELING STIMULATION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INDICATED FOR FECAL INCONTINENCE/GASTROINTESTINAL/PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT DID NOT FEEL STIMULATION AT ANY LEVEL OR ANY PROGRAM AND EXPERIENCED A RETURN OF SYMPTOMS. THE PATIENT STATED THAT THE DEVICE NOT WORKING LED TO THESE ISSUE. IT WAS MENTIONED THAT THEY HAD AN X-RAY AND APPOINTMENT WITH THEIR SURGEON. THE ISSUES WERE NOT YET RESOLVED, AND A SURGERY WAS SCHEDULED ON (B)(6) 2017 TO EITHER CORRECT THE POSITION OF THE "PROBE" OR INSERT A PROBE ON THE OTHER SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792457 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention