BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2766029 · Received October 1, 2012

    Report

    Report Number
    3004209178-2012-08694
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Report Date
    August 31, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V940002, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY AND WAS WORKING WITH HER HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. NO APPOINTMENTS WERE SCHEDULED. SUBSEQUENT INFORMATION RECEIVED TWO WEEKS LATER REPORTED THAT THE PATIENT STILL EXPERIENCED URINARY LEAKAGE. THE REPORTER STATED THAT THE NIGHT OF (B)(6) 2012, SHE WOKE UP WITH A WET PAD. IT WAS STATED THAT THE PATIENT WAS DRIPPING THROUGHOUT THE NIGHT. IT WAS NOTED THAT THE PATIENT ALWAYS HAD HER DEVICE ON FOR HER BOWEL PROBLEMS. IT WAS ALSO NOTED THAT PROGRAM 4 FELT LIKE "PINS IN HER VAGINA" AND THAT PROGRAM 3 WAS 'NO GOOD." THE REPORTER STATED, SHE INCREASED STIMULATION AT NIGHT, BUT THE STIMULATION WAS UNCOMFORTABLE. IT WAS NOTED THAT THE PATIENT HAS NOT TRIED TO TURNING OF STIMULATION TO SEE IF THE URINARY ISSUES RESOLVED. IT WAS ALSO NOTED THAT THE STIMULATION HELPED WITH 75% OF THE PATIENT'S BOWEL ISSUES. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT LOST THERAPEUTIC EFFECT. PATIENT HAD URINARY TRACT INFECTION (UTI) AND WAS ON PENICILLIN. INTERSTIM WAS IMPLANTED TO HELP WITH BOWEL SYMPTOMS AND 'IT WAS DOING VERY GOOD.' NEVERTHELESS, PATIENT WAS 'DRIPPING' DAY AND NIGHT. AT NIGHT, PATIENT WAS LEAKING FOR THE PAST FOUR WEEKS AND THIS NEVER HAPPENED BEFORE HAVING THE DEVICE. THERE IS NO KNOWN ACCIDENT OR INCIDENT RELATED WITH SYMPTOMS. AFTER VACATION, PATIENT HAD STOMACH PROBLEMS, BUT SYMPTOMS WHEN AWAY WITH MEDICINE PRESCRIBED BY DOCTOR. MEDTRONIC REPRESENTATIVE HELPED PATIENT ADJUSTING STIMULATION PARAMETERS. PROGRAM WAS CHANGED FROM 2 TO 3. PATIENT FELT STIMULATION ON THE RIGHT VAGINAL AREA AND IN THE BACK OF THE CHEEK AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LOSS OF BLADDER CONTROL WHILE USING A DEVICE FOR BOWEL CONTROL. IT WAS REPORTED THAT THE PATIENT HAD NO BOWEL CONTROL AND HER DEVICE WAS "DOING FINE" UNTIL SHE WENT ON VACATION AND CAME BACK. THE PATIENT NOTED SHE "PICKED UP A VIRUS" ON VACATION AND HAS HAD A URINARY INFECTION EVER SINCE. ANY MEDICATION THE PATIENT TOOK FOR HER INFECTION GAVE HER DIARRHEA. THE PATIENT REPORTED THAT EIGHT WEEKS PRIOR TO THE CALL HER DEVICE WAS WORKING, BUT WOULD NOT LET HER EMPTY HER BLADDER COMPLETELY. THE PATIENT TURNED OFF HER DEVICE FOR THE FIRST TIME LAST NIGHT, BUT WAS "UP ALL NIGHT PEEING". THE PATIENT WAS ASSISTED AND CHANGED TO A NEW PROGRAM, WHICH SHE STATED "FELT GOOD."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1