BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3803210 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08830
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 14, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V019740, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED TO TRY INCREASING THE VOLTAGE ON THEIR DEVICE BECAUSE THEIR SYMPTOMS HAD STARTED TO GRADUALLY GET A LITTLE WORSE A COUPLE OF MONTHS AGO. THE PATIENT PROGRAMMER WOULD NOT PERFORM TELEMETRY WITH THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WITH OR WITHOUT THE ANTENNA. IT WAS NOTED THAT THE PATIENT WAS SENT A REPLACEMENT PROGRAMMER AND WAS STILL HAVING THE SAME ISSUE WITH THE POOR COMMUNICATION SIGNAL AND WAS NOT CONNECTING WITH THEIR DEVICE. THE PATIENT TRIED TO CONNECT WITH THE ANTENNA AND THEY STILL GOT THE SAME SIGNAL. IT WAS REPORTED THAT THE PATIENT¿S INS HAD NOT BEEN CHECKED BY THEIR HEALTH CARE PROVIDER (HCP) IN A FEW YEARS AND THEY HAD NOT TALKED TO ANY MANUFACTURER REPRESENTATIVES EITHER. THE LAST TIME THE PATIENT HAD THEIR INS CHECKED, WHICH WAS A LONG TIME AGO, THEY SAID IT WOULD LAST A LONG TIME BECAUSE THE PATIENT WAS USING IT AT A LOW SETTING. IT WAS NOTED THAT THE PATIENT THOUGHT THEY HAD 10 YEARS WHEN THEY WERE TOLD THAT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ANOMALY WITH THE PROGRAMMER APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE AND THERE WAS NO INDICATION OF PATIENT HARM. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROGRAMMER¿S ANTENNA JACK WAS RESOLDERED AS FOR PREVENTATIVE MAINTENANCE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY AND RECEIVED ASSISTANCE FROM THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. AN APPOINTMENT DATE OF (B)(6) 2014 WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281937 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1