BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2130267 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03328
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): ACTUAL LONGEVITY IS < 80% OF 99.9% LONGEVITY LIMIT. THE DEVICE WAS FULLY FUNCTIONAL, WITH NO HIGH CURRENT DRAIN OR EVIDENCE OF BATTERY PROBLEMS. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT ATRIAL LEAD HAD A FAILURE TO PACE DURING THE DEVICE REPLACEMENT. THE LEAD WAS REMOVED AND ANOTHER WAS IMPLANTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. 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 CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD