BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5514304 · Received March 21, 2016

    Report

    Report Number
    3004209178-2016-05012
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    November 3, 2015
    Report Date
    April 14, 2016
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3889-28, LOT# V252847, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. REFERENCE REPORT- 6000153-2016-00660.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR ((B)(4)) SHOWED THAT THE DEVICE WAS FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. CONCLUSION CODE AND RESULT CODE NO LONGER APPLY TO THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) VIA THE MANUFACTURERS' REPRESENTATIVE (REP) REPORTED THAT FOLLOWING AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT ON (B)(6) 2016, THE DEVICE THERAPY WAS NO LONGER EFFECTIVE AND CAUSED THE PATIENT SOME DISCOMFORT. A LEAD REVISION PROCEDURE WAS DONE TO IMPROVE EFFICACY. THE IMPEDANCE TEST DEMONSTRATED 4 COMBINATIONS OUTSIDE OF NORMAL PARAMETERS. THE IMPEDANCE TEST AFTER THE IMPLANTATION OF THE NEW LEAD WAS BAD. THE 4 MONTH OLD IPG NEEDED TO BE REPLACED. IT WAS UNKNOWN IF THE ISSUE RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170444 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention