BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3191548 · Received June 26, 2013

    Report

    Report Number
    9614453-2013-01454
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    January 22, 2007
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 30932836, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. PRODUCT ID 30951036, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THE LEFT LEG DUE TO LEAD MIGRATION. IT WAS NOTED THAT THIS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290575 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 302336

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR