BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2970423 · Received February 20, 2013

    Report

    Report Number
    3007566237-2013-00556
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 388928, SERIAL# UNKNOWN,: PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A BURNING SENSATION AT THE POCKET SITE. A REVISION OF THE POCKET TO CHECK CONNECTIONS WAS PERFORMED. NO PATIENT OUTCOME WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED NO EVIDENT ANOMALY WAS FOUND WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD CONNECTION SITE WAS SURGICALLY CHECKED. THE PATIENT CONTINUED TO HAVE COMPLAINT OF BURNING AT THE LEVEL OF THE POCKET. IT WAS NOTED THE PATIENT WAS RECEIVING THERAPY FROM THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74446 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention