BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4844486 · Received June 15, 2015

    Report

    Report Number
    3004209178-2015-11593
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENTS BOTH WITH AND WITHOUT THE ANTENNA ATTACHED. THE PATIENT HAD THE STIMULATION OFF FOR ONE WEEK AND SHE WAS GOING TO TURN IT BACK ON. THE HEALTH CARE PROFESSIONAL (HCP) HAD THE PATIENT TURN OFF THEIR THERAPY TWICE A YEAR, "TO GIVE THE NERVES A VACATION OR BREAK FROM BEING STIMULATED." NO THERAPY ISSUES WERE REPORTED. THE PATIENT WAS UNABLE TO CONNECT WITH AND WITHOUT THE ANTENNA. THE PATIENT HAD NOT SEEN ANY LOW BATTERY SCREEN. THE PATIENT RECEIVED A NEW REPLACEMENT PROGRAMMER, AND SHE WAS HAVING THE SAME ISSUES. INTERVENTIONS AND PATIENT OUTCOME WERE NOT PROVIDED. FOLLOW UP WAS REQUESTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389273 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR