BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6326174 · Received February 13, 2017

    Report

    Report Number
    3004209178-2017-03727
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 25, 2016
    Report Date
    February 13, 2017
    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
    MI, 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

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY HAD A RETURN OF BOWEL SYMPTOMS AROUND TWO MONTHS AGO. PATIENT STATED THAT THEY GOT HER 1 YR ANNIVERSARY CARD AND IT SAID PATIENT HAD INTERSTIM THERAPY FOR "BLADDER CONTROL." PATIENT STATED THAT THEY GOT DEVICE FOR BOWEL CONTROL AND THEN WENT TO SAY THAT THEIR DOCTOR ONLY DEALT WITH THE BOWELS BUT THAT A PROGRAM THEY WERE ON DURING THEIR TRAIL HELPED WITH THEIR BLADDER SYMPTOMS. THE PATIENT STATED THAT THE PERMANENT IMPLANT HAD NEVER HELPED WITH THEIR BLADDER SYMPTOMS. THE PATIENT MENTIONED THAT THEIR IMPLANT LOOKED LIKE IT WAS "SINKING" AND THAT IT SEEMED LIKE IT HAD MOVED FROM WHERE IT USED TO BE LOCATED AROUND TWO MONTHS AGO. THE PATIENT STATED THAT THEY HAD SEEN THEIR HCP FOR THE BOWEL SYMPTOMS AND PATIENT STATED THAT THEY HAD QUIT TAKING ABOUT ALL THEIR MEDICATIONS (PT STATED CODEINE AND NARCO) AND JUST WENT TO HERBS AND SPICES AND THEN HAD CONSTANT DIARRHEA. THE PATIENT STATED THE HCP TOLD THEM TO START TAKING IMMODIUM (1 IN MORNING 1 AT NIGHT FOR 2 MONTHS) AND THEY WERE STILL HAVING PROBLEMS. THE PATIENT STATED THAT THE BOWEL SYMPTOMS NOT BEING CONTROLLED WAS BECAUSE OF THEIR BODY NOT THE STIMULATOR AND THEY SAID THAT THEIR HCP TOLD HER THAT IT WAS FROM THE CHANGE IN HER BODY FROM STOPPING TAKING THOSE MEDICATIONS THAT CAUSED THE BOWEL SYMPTOMS. THE PATIENT STATED THAT THEY HAD HIT THE UPPER LIMIT ON 2 OUT OF HER 4 PROGRAMS (P3 AND PATIENT WASN'T SURE WHICH OTHER PROGRAM). PATIENT WAS CURRENTLY ON P2 AND CHANGED TO P1 DURING CALL WITHOUT DIRECTION OF REPRESENTATIVE. IT WAS REVIEWED CHANGING PROGRAMS WAS PER HEALTHCARE PROFESSIONAL (HCP) DIRECTION AND PATIENT STATED HCP HAD GIVEN THEM PERMISSION. PATIENT WAS ASSISTED IN INCREASING STIMULATION ON P1 TO 5.7 WHERE PATIENT FELT STIMULATION COMFORTABLY. PATIENT WAS IMPLANTED FOR GASTROINTESTINAL/ PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110005 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR