BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5682469 · Received May 26, 2016

    Report

    Report Number
    3004209178-2016-10417
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    January 1, 2010
    Report Date
    May 26, 2016
    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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V012404, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. 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

    THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE LAST TIME THE PATIENT WAS SEEN IN THE CLINIC WAS IN 2010 AND THE ELECTRODE COMBINATIONS OF 0 <(>&<)> 2 AND 0 <(>&<)> 3 SHOWED IMPEDANCES GREATER THAN 4,000 OHMS. THE MANUFACTURER REPRESENTATIVE (REP) LATER REPORTED THAT THE PATIENT HAD SURGERY FOR NORMAL BATTERY DEPLETION ON (B)(6) 2016. THE OLD IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED AND A NEW INS WAS IMPLANTED. THE CHRONIC LEAD WAS INSERTED INTO THE HEADER BLOCK, BUT THE IMPEDANCES WERE NOT GOOD. THE OLD LEAD WAS REMOVED AND A NEW LEAD IMPLANTED TO RESOLVE THE ISSUE. THERE WERE NO ASSOCIATED SYMPTOMS. THE PATIENT'S INDICATION(S) FOR USE WERE URINARY DYSFUNCTION AND SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336857 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention