BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3689670 · Received March 20, 2014

    Report

    Report Number
    3004209178-2014-04695
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Report Date
    February 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3889-28, LOT# V881399, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3889-28, LOT# VA00A5S, IMPLANTED: (B)(6) 2012, 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 WAS REQUESTING AN APPOINTMENT WITH A MANUFACTURER'S REPRESENTATIVE STATING HE WAS HAVING TROUBLE WITH HIS STIMULATOR. THE PATIENT ASKED FOR HELP WITH REPROGRAMMING. THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. A FEW WEEKS AGO THE PATIENT STARTED HAVING ISSUES. THE PATIENT WOULD HAVE THE SETTING CORRECT AND THEN ON ITS OWN IT GOES AWAY "GOES TO ZERO AGAIN." SEE ALSO MANUFACTURER'S REPORT # 3004209178-2014-04694. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165577 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR