BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4221638 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20874
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-33, LOT# VA0CL80, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL WHILE TRAVELING AND WENT TO THE ER. A CAT SCAN WAS PERFORMED AND THEY ¿SAID THE DEVICE DOESN¿T LOOK LIKE IT IS IN THE RIGHT SPOT¿. IT WAS ALSO NOTED THAT ¿THEY DON¿T KNOW ANYTHING ABOUT IT AT THE ER¿. THE PATIENT WAS IN A LOT OF PAIN AND HAD BEEN HAVING THE PAIN SINCE THE DAY OF THE FALL. IT WAS SUGGESTED THAT THE PATIENT REACH OUT TO A LOCAL DOCTOR TRAINED IN THE THERAPY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702313 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR