BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3241326 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12113
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS : PRODUCT ID 3889-28, LOT# V462932, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO THE BATHROOM 3-4 TIMES AT NIGHT. IT WAS REPORTED THAT WHEN THE PATIENT WAS LYING DOWN AND THEN STOOD UP "URINE JUST CAME OUT." THE PATIENT WAS UNABLE TO MAKE IT TO THE BATHROOM. IT WAS NOTED THAT IT DIDN'T SEEM TO HAPPEN WHEN THE PATIENT WAS UP WALKING. IT WAS REPORTED THAT THE PATIENT COULD USUALLY MAKE IT TO THE BATHROOM, BUT SHE DID STILL WEAR A PAD. IT WAS REPORTED THAT THE PATIENT HAD SOME ISSUES BEFORE HER HIP REPLACEMENT SURGERY ON (B)(6) 2013 BUT WOULD CHANGE PROGRAMS OR "DO SOMETHING ELSE" AND IT WOULD BE OK. IT WAS REPORTED THAT IT WAS WORSE AFTER THE SURGERY. THE PATIENT TRIED DIFFERENT PROGRAMS AND IT DIDN'T SEEM TO HELP. IT WAS NOTED THAT THE PATIENT DIDN'T KNOW IF HER VICODIN THAT SHE TOOK IN THE MORNING AND AT NIGHT WOULD AFFECT THIS. IT WAS NOTED THAT THE PATIENT HAD NO MORE SWELLING AND ONLY HAD A LITTLE PAIN FROM THE SURGERY, BUT DIDN'T FEEL THE STIMULATION AS MUCH AND PROGRAM 1 AND 2 DIDN'T DO ANYTHING. THE PATIENT WAS ON VICODIN UNTIL SHE COULD GET BACK ON HER ARTHRITIS MEDICATIONS. THE PATIENT HAD AN APPOINTMENT WITH HER HCP SCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339974 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR