BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5128455 · Received October 5, 2015

    Report

    Report Number
    3004209178-2015-20015
    Event Type
    Injury
    Date Received
    October 5, 2015
    Report Date
    September 15, 2015
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS ((B)(4)) FOUND THAT THE INS WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. THE INS FUNCTIONED PROPERLY THROUGHOUT THE DURATION OF A LONG TERM MONITOR TEST. THE INS WAS SET TO THE PARAMETERS THE DEVICE HAD WHEN RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 388928, LOT# 0209242854, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT, VIA THE MANUFACTURER REPRESENTATIVE, REPORTED THEY EXPERIENCED AN UNPLEASANT JOLTING SENSATION. THE PATIENT TURNED THE DEVICE OFF AND IMPEDANCE TESTING WAS DONE AT 0.8V. ALL COMBINATIONS WITH THE CASE WERE IN NORMAL RANGE (897-1080 OHMS). ELECTRODE COMBINATION 0 AND 2 TESTED AT 1616 OHMS AND ALL OTHER ELECTRODES WERE GREATER THAN 4 ,000 OHMS. THE MANUFACTURER REPRESENTATIVE PROGRAMMED A SETTING TO GIVE COMFORTABLE STIMULATION, BUT THE PATIENT WANTED THE DEVICE TURNED OFF AND THE SYSTEM REMOVED. AN X-RAY WAS ORDERED, BUT NO RESULTS WERE PROVIDED. THE SYSTEM WAS EXPLANTED AND THE ISSUE WAS RESOLVED. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658081 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention