BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3233154 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11938
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 14, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR, SERIAL #: (B)(4), FOUND NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V487156, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) NO LONGER APPLIES TO THE EVENT. METHOD, RESULT, AND CONCLUSION CODES HAVE BEEN UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT NO STIMULATION. ALL UNIPOLAR AND BIPOLAR PAIRS WERE SHOWING IMPEDANCE READINGS GREATER THAN 4,000 OHMS. THE REPORTER WAS UNSURE WHEN THE PATIENT LOST STIMULATION. THERE HAD BEEN NO PATIENT FALLS OR TRAUMA. THE PATIENT¿S SYSTEM WAS REPLACED AND WAS FEELING ¿GOOD THERAPY¿ WITH THE NEW IMPLANT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT HAD A REVISION OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) DONE DUE TO FLUID IN THE POCKET IN (B)(6) 2013. THERE WERE NO SYSTEM USE ISSUES. THE PATIENT RECOVERED COMPLETELY. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER REPORTED THAT THERE WAS A MALFUNCTION OF THE NEUROSTIMULATOR. THE IMPEDANCE WAS GREATER THAN 4000 OHMS. THERE WAS NO CLINICAL REQUEST. THE CAUSE OF THE FLUID IN THE POCKET WAS NOT DETERMINED. THE INDICATION FOR USE FOR THIS PATIENT WAS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333609 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention