BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3930376 · Received July 11, 2014

    Report

    Report Number
    3004209178-2014-12937
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V604559, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4);PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL 2 WEEKS PRIOR TO THIS CALL. THE PATIENT THOUGHT THE DEVICE MOVED A LITTLE BIT. THE PATIENT COULD NOT URINATE AND THIS CAME ON GRADUALLY AND SHE ENDED UP WITH A BAD INFECTION. THE PATIENT MADE AN ADJUSTMENT AND THE DEVICE WAS WORKING BUT NOT AS WELL AS IT WAS BEFORE. THE PATIENT FELT BURNING SENSATION ON HER SKIN BY HER IMPLANT, AND THIS CAME ON GRADUALLY. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406094 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention