BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3738396 · Received April 10, 2014

    Report

    Report Number
    3004209178-2014-05938
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V190606, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. APPOINTMENT WAS (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN HAVING PROBLEMS WITH THEIR DEVICE SINCE AN EKG. IT WAS NOTED THE PATIENT DID NOT TURN THEIR DEVICE OFF FOR THE EKG. IT WAS REPORTED THE PATIENT¿S DEVICE WAS NOT WORKING. IT WAS NOTED THE PATIENT HAD CATARACTS SURGERY A WEEK AFTER THE EKG, BUT THE ISSUE STARTED WITH THE EKG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217955 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR