BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2928393 · Received January 24, 2013

    Report

    Report Number
    3004209178-2013-00924
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Report Date
    December 31, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V062916, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3031A LOT# SERIAL# (B)(4), IMPLANTED: 2001 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S LEADS HAD "DISLODGED" A "FEW YEARS AGO". NO FURTHER INFORMATION ABOUT THIS EVENT WAS GIVEN. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT. FOR MORE INFORMATION ABOUT THIS DEVICE PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2013-00613.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33538 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1