BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6170895 · Received December 13, 2016

    Report

    Report Number
    3004209178-2016-26356
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 5, 2014
    Report Date
    January 17, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL FOR A CLINICAL STUDY (VIA A MANUFACTURER REPRESENTATIVE) REGARDING A PATIENT WITH FUNCTIONAL IDIOPATHIC URINARY INCONTINENCE SINCE 2004. IT WAS REPORTED THE PATIENT EXPERIENCED TOO STRONG STIMULATION AT THE GROIN LEVEL ON (B)(6) 2016, NOTING DISCOMFORT. ON (B)(6) 2016, THE DEVICE WAS REPROGRAMMED AND THE PATIENT RECOVERED. THERE WAS ¿NO DEVICE ISSUE¿ AND THE EVENT WAS RELATED TO THE NEUROSTIMULATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE REP REPORTED THE EVENT OCCURRED ON (B)(6) 2014. REPROGRAMMING WAS DONE IN ORDER TO RESOLVE THE ISSUE AND IT WAS NOTED TO BE RESOLVED ON (B)(6) 2014. THERE WAS NOT DEVICE ISSUE DUE TO THE STRONG STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821550 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR