BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5138965 · Received October 8, 2015

    Report

    Report Number
    3004209178-2015-20324
    Event Type
    Injury
    Date Received
    October 8, 2015
    Report Date
    December 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V021931, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN URINATING A LOT FOR THE LAST WEEK AND A HALF. THE PATIENT CATHETERIZED HERSELF PER DOCTOR'S ORDERS, BUT SHE STILL FELT URGENCY. THE PATIENT KNEW SHE DID NOT HAVE A URINARY TRACT INFECTION. THE PATIENT HAD MORE FREQUENCY PROBLEMS FOR A WEEK AND A HALF BUT DOES NOT HAVE A UTI. THE PATIENT HAD CATHETERIZED BUT WAS STILL FEELING URGENCY. PATIENT SERVICES SPOKE TO THE MANUFACTURER'S REPRESENTATIVE, WHO STATED SHE WAS MADE AWARE OF THIS SITUATION (B)(6) 2013. THE REPRESENTATIVE SPOKE TO THE PATIENT ON THAT DATE AND INSTRUCTED HER TO TURN THE STIMULATION UP TO RESOLVE HER SYMPTOMS ONLY IF IT WAS COMFORTABLE. THE PATIENT HAD TURNED THE STIMULATION DOWN BUT THAT WAS NOT SUCCESSFUL IN RESOLVING HER SYMPTOMS. PATIENT SERVICES SPOKE TO THE PATIENT'S BROTHER-IN-LAW, WHO TOOK DOWN INSTRUCTIONS ON HOW TO ADJUST STIMULATION AND CHANGE PROGRAMS. THE PATIENT HAD BEEN TO THE E.R. BEFORE AND THEY COULD NOT DO ANYTHING FOR HER SNM THERAPY PROBLEM THERE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A "BURNING" IN THEIR COCCYX/RECTAL AREA AND FELT THIS REGULARLY. THIS ISSUE HAD GOTTEN WORSE ABOUT 2 WEEKS. IT WAS NOTED THAT THE HIGHER THE STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) THE MORE THEY FELT THE PAIN. THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) INSTRUCTED THE PATIENT TO TURN THE INS DOWN AND THIS HELPED "SOMEWHAT". IT WAS NOTED THAT THE PATIENT HAD BEEN URINATING A LOT THE PAST WEEK AND A HALF. THE PATIENT CATHETERIZED THEMSELVES PER THEIR DOCTOR'S ORDERS BUT THAT THEY STILL FELT URGENCY. THE PATIENT STATED THAT THEY "KNEW" THEY DID NOT HAVE A URINARY TRACT INFECTION. IT WAS ALSO NOTED THAT THE PAIN HAD PUDENDAL NEURALGIA WHICH CAUSES PAIN IN THE COCCYX AREA AND THAT THEY WERE TAKING HYDROCODONE WHICH MADE THEIR PAIN GO AWAY. THE PATIENT WAS INDICATED FOR GASTROINTESTINAL/ PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667195 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Other