BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3082246 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-06993
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 3037,SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA05NGV, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PRE-PROGRAMMED PRIOR TO IMPLANT AND LATER SHOWED A POWER ON RESET (POR) MESSAGE ON THE PATIENT PROGRAMMER (PP). THE INS WAS INTERROGATED AND SYNCED 'FINE' WITH THE PP AND THE POR WAS CLEARED. THE INS WAS CHECKED WITH THE PP AFTER IT WAS INTERROGATED WITH A PHYSICIAN PROGRAMMER AND PROGRAMMING WAS INTACT AND THERE WAS NO POR MESSAGE. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE POR WAS SEEN IMMEDIATELY POST-OP AND MAY HAVE BEEN RELATED TO THE CAUTERY PERFORMED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185606 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR