BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 4162569 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19357
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 26, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. PRODUCTS: 419688 LEAD IMPLANTED 2010 (B)(6); 407645 LEAD IMPLANTED 2010 (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS MOVING ABOUT THE POCKET AFTER SIGNIFICANT WEIGHT LOSS, CAUSING THE PATIENT CONSIDERABLE PAIN WHEN PERFORMING DAILY ACTIVITIES. A POCKET REVISION WAS DISCUSSED AND THE ICD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE ICD WAS REPOSITIONED AND THE PAIN HAD SUBSIDED PER THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643607 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R 694758 LEAD