BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3023333 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04296
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 7, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-33 LOT# VA03RMG, IMPLANTED: 2013 (B)(6) PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION NEAR THE (B)(6). IT WAS UNCLEAR IF THE PROBLEMS WERE RELATED TO THE IMPLANTED SYSTEM. THE REPORTER HOWEVER, INDICATED THAT THERE WAS AN ISSUE WITH A "WIRE" IN THE PATIENT'S SYSTEM THAT WAS FIXED WITH THE SURGERY. AFTER THE LEAD REVISION, THE PATIENT GOT SYMPTOM CONTROL FOR A WEEK, BUT HADN'T HAD SYMPTOM CONTROL SINCE THEN. THE PATIENT COULD FEEL STIMULATION BUT WAS HAVING TO GO TO THE BATHROOM EVERY TWO HOURS. AT THE TIME OF THE INITIAL REPORT, IT WAS DETERMINED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON AND AT 2.0V, FROM A PREVIOUS SETTING OF 1.1V A COUPLE OF DAYS PRIOR. THE PATIENT'S PROGRAM AND AMPLITUDE SETTINGS WERE CHANGED, AFTER WHICH THE PATIENT COULD STILL FEEL STIMULATION. THE REPORTER INDICATED THAT THE PATIENT WAS GOING TO TRY THAT SETTING AND WAS SCHEDULED FOR AN APPOINTMENT WITH HER HEALTHCARE PROVIDER (HCP) THE FOLLOWING WEEK. IT WAS LATER REPORTED THAT THE PATIENT'S DEVICE WAS REPROGRAMMED AND THE PATIENT DID NOT HAVE PROBLEMS WITH HER SYSTEM. THE PATIENT'S DEVICE WAS WORKING BETTER AND THINGS WERE "WONDERFUL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125790 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention