BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4210326 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20593
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 13, 2014
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0FXGG, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INCREASED URINARY LEAKAGE. UPON INTERROGATION, SEVERAL ¿LEADS¿ WERE FOUND TO HAVE ABNORMAL HIGH IMPEDANCE. THE EVENT WAS NOTED TO BE RELATED TO THE LEAD AND PROGRAMMING. THE DEVICE WAS REPROGRAMMED ON (B)(6) 2014, AND THE EVENT RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) FOR A CLINICAL STUDY, VIA A MANUFACTURER REPRESENTATIVE, REPORTED THE EVENT WAS NOT RELATED TO PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694158 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR