BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3923800 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12765
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA090J8, IMPLANTED: (B)(6) 2013, 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 AFTER THE IMPLANT PROCEDURE, THE PATIENT FELT ¿WOOZY¿ AND FAINTNESS. IT WAS LATER THAT EVENING THAT THE PATIENT STARTED GETTING A FEVER AND THE INCISION SITE FELT WARM/HOT TO THE TOUCH. THE PATIENT COULD NOT BE SEEN BY THE IMPLANTING SURGEON, BUT WAS ABLE TO SEE THE NURSE WHO DID HER REPROGRAMMING. THE PATIENT WAS THEN SEEN BY A DIFFERENT HCP AND IT WAS DETERMINED TO PUT THE PATIENT ON ANTIBIOTICS FOR A FEW DAYS AND IT RESOLVED. IT WAS NOTED THAT THE HCP USED A BANDAGE THAT DISSOLVED OVER TIME TO COVER THE INCISION SITE. IT WAS ALSO NOTED THAT AFTER IMPLANT, THE MANUFACTURER REPRESENTATIVE DID NOT SHOW THE PATIENT HOW TO WORK THE PATIENT PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401586 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention