BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3162764 · Received June 11, 2013

    Report

    Report Number
    9614453-2013-01432
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    March 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A ¿PRIOR REACTION¿ WHEN GOING THROUGH SECURITY DEVICES. IT WAS UNCLEAR WHAT ¿PRIOR REACTION¿ REFERRED TO. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262402 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 7427T14

    Patients

    Seq Age Sex Outcome Treatment
    1