BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 3062166 · Received April 16, 2013

    Report

    Report Number
    9612164-2013-00427
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LEFT VENTRICULAR (LV) LEAD IMPLANT, WHEN TRYING TO SLIT THE CATHETER, THE SUTURE SLEEVE ON THE LEAD WAS IN THE WAY AND THE LEAD BECAME SEVERLY KINKED. IT WAS ALSO REPORTED THAT THE PHYSICIAN PREFERS TO USE THE LONGER CATHETER FOR DELIVERY WITH A SHORTER THAN USUAL LV LEAD. THE CATHETER WAS REMOVED AND ANOTHER CATHETER WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162319 N/A DQY 624890D02 0006525126

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR