BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5084739 · Received September 17, 2015

    Report

    Report Number
    3004209178-2015-18162
    Event Type
    Injury
    Date Received
    September 17, 2015
    Report Date
    August 24, 2015
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V260716, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALL WAS ABOUT THE PATIENT PROGRAMMER. THEY WERE TRYING TO INCREASE STIM BUT GETTING UPWARD ARROW AND WANTED TO KNOW WHAT IT MEANT. EVENT DATE WAS NOTED AS (B)(6) 2015. THE PATIENT HAD BEEN WETTING HER PANTS AND THEY HAD BEEN TRYING TO INCREASE STIM. THEY HAD INCREASE AND DECREASE STIM. SETTING WAS PROGRAM 4 AT 7.2V. THERAPY WAS ON. CALLER STATED HE WILL TRY TO CHANGE PROGRAM AND WILL CONTACT HCP (HEALTHCARE PROVIDER) OFFICE. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT DID HAVE GREATER THAN 50% SYMPTOM RELIEF BUT NEEDED TO BE TAUGHT HOW TO USE THE PROGRAMMER. IT WAS NOTED THAT THE PATIENT ALSO HAD A URINARY TRACT INFECTION WHICH WOULD EXPLAIN THE INCREASE SYMPTOMS. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PATIENT WAS IMPLANTED FOR URINARY DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615925 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention