BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3803145 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08828
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    February 5, 2014
    Report Date
    April 16, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3093-28, LOT# V826029, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY URGENCY AND FREQUENCY. THERE WAS A DEVICE USAGE PROBLEM OF DEVICE MALFUNCTION THAT WAS THAT THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. IT WAS NOTED THAT THERE WAS A PRODUCT PROBLEM. THE DATE OF THE EVENT WAS 2014-(B)(6). IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED IN (B)(6) 2014 AND THE DEVICE WAS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281384 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention