BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD NEURO

    MDR report key: 2172154 · Received June 15, 2011

    Report

    Report Number
    3007566237-2011-04454
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-500-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, FOR THE MODEL 3550-39 TITAN ANCHOR DUE TO THE POTENTIAL FOR LEAD MIGRATION AS A RESULT OF INSERT SEPARATION WITHIN THE ANCHOR. PHYSICIAN COMMUNICATION (OCTOBER, 2009).

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE, IT WAS NOTICED THAT THE TITANIUM AND SILICON PARTS OF THE TITAN ANCHOR WERE DISCONNECTED. THE HEALTH CARE PROFESSIONAL TRIED TO FIX THEM WITH STITCHES. A RADIO SCAN CONTROL WAS PERFORMED AND SHOWED THAT NOTHING WAS MOVED. THE TITAN ANCHOR REMAINED IMPLANTED AND IN USE WITHOUT ANY PROBLEM. THE PT WAS NOT INJURED AND WAS OKAY. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD NEURO LGW MEDTRONIC NEUROMODULATION LEADN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR STIM ACCESSORY: MODEL 3550-39, LOT# N286595| IMPLANTED:| EXPLANTED: