BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBS LEAD

    MDR report key: 2182337 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05271
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACTIVA IMPLANT PROCEDURE, THE LEAD CAME OUT OF THE BOX DAMAGED. THE LEAD TIP LOOKED BULBOUS AND MISALIGNED. THE LEAD WAS NOT USED IN THE PT AND DIFFERENT LEADS WERE USED INSTEAD. THERE WERE NO PT INJURIES AND THE PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBS LEAD MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 3389S-40 V621021

    Patients

    Seq Age Sex Outcome Treatment
    1