BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4182419 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19941
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 24, 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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# UNKNOWN, IMPLANTED: (B)(6) 2009, 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 A PATIENT WAS NO LONGER FEELING STIMULATION, WHICH STARTED ABOUT A MONTH PRIOR TO THE REPORT. THE PATIENT TRIED CHECKING THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PATIENT PROGRAMMER THE PRIOR DAY BUT COULDN¿T CONNECT. A HEALTHCARE PROFESSIONAL WAS UNABLE TO CONNECT TO THE INS USING THE CLINICIAN PROGRAMMER THE DAY OF THE REPORT. IN (B)(6) 2012 THE IMPLANT WAS AT 35 PERCENT TO 50 PERCENT BATTERY LIFE. THE PATIENT¿S SETTINGS AS OF (B)(6) 2014 WERE 2+, 0- AT 2.8 VOLTS, 14 HERTZ, 210 MICROSECONDS WITH CYCLING OF 8 SECONDS ON, AND 20 SECONDS OFF. END OF SERVICE (EOS) WAS ESTIMATED TO OCCUR AT 5.1 YEARS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661567 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR