BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3843806 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09979
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3886, LOT# J0204999V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER WAS ASKING ABOUT STIMULATOR AND MRI. CALLER WAS MRI CLINICIAN. THEY WANT TO SCAN THE L-SPINE. AGENT ASKED, WAS THE MRI TO DIAGNOSE A DEVICE OR THERAPY PROBLEM WITH IMPLANT. THE CALLER STATES YES, IT'S IN SAME AREA SO HE WAS ASSUMING SO. THE FOLLOW UP PHYSICIAN MOST FAMILIAR WITH SITUATION WAS UNKNOWN AND EVENT DATE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321306 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1