BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3191109 · Received June 26, 2013

    Report

    Report Number
    9614453-2013-01450
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    January 7, 2005
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 38892836, LOT# B0249591K, IMPLANTED: 2004-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 30951036, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN AN ACCIDENT WITH THE EXTENSION WIRE. THREE OUT OF THE FOUR WIRES BROKE. THE EXTENSION LEAD GOT TAPPED. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291090 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR