BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5519989 · Received March 23, 2016

    Report

    Report Number
    3004209178-2016-05179
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    February 1, 2016
    Report Date
    August 19, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION DATE IS APPROXIMATE.

    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 SHE HAD CHANGE OF THERAPY; SHE HAD LOOSE BOWELS TWICE. IT HAPPENED ONE TIME THE DAY PRIOR TO THIS REPORT AND MAYBE THE THURSDAY PRIOR TO THIS REPORT. SHE WAS NOT FEELING STIMULATION AND THERAPY WAS ON. THE PATIENT WAS ON PROGRAM2 AT 1.3 VOLTS. IT WAS NOTED THAT SHE HAD SOME SHOTS IN HER NECK ON (B)(6) 2016. NO TRAUMA/FALLS WERE RELATED. THE PATIENT WAS INSTRUCTED IN CHANGING TO PROGRAM 1 AT 2.4 VOLTS. ON THE NEW PROGRAM, SHE DIDN'T FEEL THE JABBING IN THE VAGINAL AREA. WHEN SHE WAS STANDING OR WALKING, SHE FELT JABBING IN THE VAGINAL AREA. THE JABBING HAD OCCURRED FOR THE LAST 2 WEEKS. THE PATIENT WAS REDIRECTED TO HER HEALTHCARE PROVIDER (HCP). INDICATIONS FOR USE WERE FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THE PATIENT HAD HAD APPOINTMENTS WITH THEIR HEALTHCARE PROVIDER (HCP) ON (B)(6) 2016 AND (B)(6) 2016, AND SOME DATES BEFORE THEN. THE CIRCUMSTANCES THAT HAD LED TO THE SYMPTOMS WERE THE PATIENT HAD CHANGED THEIR DEVICE PROGRAM AND THE STEPS TAKEN TO RESOLVE THE ISSUE WERE THE PATIENT NEEDED TO CHANGE THEIR PROGRAM. THE JABBING IN THE VAGINAL AREA AND LOOSE BOWELS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175257 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR