BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUNDER

    MDR report key: 4673593 · Received March 31, 2015

    Report

    Report Number
    4673593
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 26, 2015
    Manufacturer
    DANEK MEDTRONIC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE TIP OF SOUNDER BROKE OFF INTO PEDICLE AND WAS NOT ABLE TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213355 SOUNDER PEDICLE FINDER KWQ DANEK MEDTRONIC 8572102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR