BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3182909 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10720
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V892719, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND BLADDER CONTROL. IT WAS STATED THAT ¿IT WAS NOT WORKING¿ SINCE THE THIRD WEEK AFTER THE IMPLANT. THE PATIENT DID NOT WEAR A PAD DURING THE FIRST THREE WEEKS, BUT THEN ¿IT JUST STOPPED.¿ IT WAS NOTED HOWEVER, THAT IT ¿MIGHT BE WORKING A TAD.¿ NO FALLS OR TRAUMAS WERE REPORTED IN RELATION. THE PATIENT HAD BEEN ¿REAL, REAL CAREFUL.¿ STIMULATION WAS CURRENTLY AT 1.3V ON PROGRAM 1, AND WAS FELT ON THE INSIDE OF THEIR RECTUM, ¿IN THE BUTT CHEEK.¿ THE PATIENT HAD TRIED ALL FOUR PROGRAMS, AND IT WAS STATED THAT PROGRAM 1 WORKED THE BEST. IF STIMULATION WAS INCREASED, IT WOULD BECOME ¿TOO PAINFUL¿ IN THE VAGINA. THE PATIENT ALSO EXPERIENCED PAIN FROM THE IMPLANTABLE NEUROSTIMULATOR INCISION DOWN TO THEIR TAILBONE. THERE WAS NO PATTERN TO THE ACHING OR PAIN, AND IT SEEMED TO BE RANDOM. IT WAS NOTED THAT THERE HAD BEEN 4-5 REPROGRAMMING SESSIONS, BUT THE PATIENT WAS ¿WETTING AS MUCH AS EVER,¿ IN ADDITION TO URGENCY. AT THE PREVIOUS OFFICE VISIT, IT WAS INDICATED THE DOCTOR WANTED THE PATIENT TO TRY ANOTHER MEDICATION. IT WAS ADDED THAT THE PATIENT HAD FREQUENT BLADDER INFECTIONS AS WELL. THE PATIENT¿S NEXT APPOINTMENT WITH THEIR DOCTOR WAS IN (B)(6) 2013. ABOUT A WEEK LATER, IT WAS INDICATED THE PATIENT HAD CHRONIC BLADDER INFECTIONS BEFORE THE DEVICE WAS IMPLANTED. THE PATIENT HAD BEEN ON A LOW-DOSE DAILY ANTIBIOTIC ¿FOR A WHILE¿ TO PREVENT THE INFECTIONS. THE PATIENT WAS SEEN BY THE HEALTHCARE PROVIDER (HCP) IN (B)(6) 2013. AT THAT POINT, THE PATIENT HAD A ¿SIGNIFICANT¿ IMPROVEMENT WITH THE DEVICE. IN (B)(6) 2013, IT WAS NOTED THE PATIENT ¿WISHED¿ THEY HAD MORE IMPROVEMENT. THE PATIENT WAS ALSO PUT ON A TRIAL OF A NEW DRUG FOR THE INFECTIONS. THE HCP THOUGHT THAT THE DEVICE WAS HELPING THE PATIENT. AS OF (B)(6) 2013, THE PATIENT WAS ¿FINE.¿ THEY WERE FEELING STIMULATION IN THE VAGINAL AREA, BUT STILL HAD FREQUENCY AND URGENCY. NO FURTHER INTERVENTIONS HAD BEEN PLANNED. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283063 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention