BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2851630 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10957
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 4, 2012
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA01ZRC, 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 DEVICE CHANGED PROGRAMS AFTER PASSING THROUGH A METAL DETECTOR. THE REPORTER STATED THAT SHE WENT TO CHECK THE BATTERY STATUS AND NOTICED THE PROGRAM CHANGED FROM PROGRAM 2 AT 2.3 VOLTS TO PROGRAM 1 AT 0.0 VOLTS. IT WAS NOTED THAT THE PATIENT WORKED WITH HER HEALTH CARE PROVIDER (HCP) TO SWITCH THE PROGRAMMING BECAUSE THE PATIENT HAD DIARRHEA FOR THE PAST FEW DAYS. IT WAS ALSO NOTED THAT THE PATIENT WANTED TO RETURN TO THAT PROGRAM. THE REPORTER STATED THAT SHE SYNCED AND WAS ON PROGRAM 2 AT 1.0 VOLTS AND DID NOT FEEL STIMULATION. THE REPORTER THEN SET THE STIMULATION 'COMFORTABLY' AT 1.2 VOLTS. ADDITIONAL INFORMATION RECEIVED TWO WEEKS LATER REPORTED THAT THE PATIENT HAD RECEIVED ASSISTANCE FROM HER HCP OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1