BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3190466 · Received June 26, 2013

    Report

    Report Number
    9614453-2013-01447
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    November 15, 2005
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4). LOT# B0192364K, IMPLANTED: 2003-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 7495-10, SERIAL# (B)(4), IMPLANTED: 2003-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED SENSATION OF STIMULATION WHILE STANDING NEXT TO A NEW ALARM SYSTEM. AFTER REP ROGRAMMING NO COMPLAINTS WERE PRESENT. ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291403 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 302336

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR