BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4054391 · Received September 3, 2014

    Report

    Report Number
    3004209178-2014-16269
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    November 1, 2011
    Report Date
    August 11, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V842736, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE DEVICE WAS NOT WORKING SINCE IMPLANT AND THE PATIENT HAD MULTIPLE ADJUSTMENTS. IT WAS NOTED THAT THE PATIENT WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) AND THEY WANTED TO DO AN IMPLANTABLE NEUROSTIMULATOR (INS) ON THE OTHER SIDE. TESTING HAD BEEN DONE ON THE DEVICE AND NO MALFUNCTION WAS REPORTED. IT WAS STATED THAT THE PATIENT HAD ONE ADJUSTMENT WHERE THEY WERE LEAK FREE FOR 2 DAYS, BUT THEN THE LEAKING CAME BACK ON DAY 3. THE PATIENT WANTED TO KNOW WHO THEY SHOULD WORK WITH FOR MOVING FORWARD ON THEIR SECOND IMPLANT. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE NEVER RETURNED THE PATIENT¿S PHONE CALLS. THE MANUFACTURER REPRESENTATIVE WOULD CALL THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SCHEDULING A REVISION WITH THEIR HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537925 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention