BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4243635 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21326
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 31, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# VA0BN8L, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED BECAUSE SHE WANTS SOMEONE TO BE AT HER APPOINTMENT IN (B)(6). THE DEVICE HAS NEVER WORKED WELL/ NEVER BEEN EFFECTIVE. ABOUT A MONTH AND A HALF AGO SHE STARTED GETTING CONSTANT UTIS (URINARY TRACT INFECTIONS). SHE WAS TAKING ANTIBIOTICS "COMING OUT HER REAR" AND NOTHING WAS HELPING. THE PATIENT HAS NEVER HAD AN INFECTION IN HER LIFE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727873 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention