BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO II CRT-D

    MDR report key: 1719096 · Received June 11, 2010

    Report

    Report Number
    6000144-2010-02994
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    March 29, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED INDICATED THE PATIENT WAS DECEASED AND DIED APPROXIMATELY ONE YEAR AFTER LEAD/HEADER CONNECTION WAS MODIFIED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2011 AND REVEALED THE PATIENT WAS DECEASED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD INTEGRITY ALERT TRIGGERED. IT WAS DETERMINED THAT THE LEAD HAD NOT BEEN SCREWED IN TIGHT ENOUGH IN THE CONNECTOR. THE SETSCREW WAS RETIGHTENED AND IMPEDANCE WAS FOUND TO BE IN RANGE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H| R 1488T COMPETITOR IMPLANTABLE PACING LEAD| 1488T COMPETITOR IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD