BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1792576 · Received August 11, 2010

    Report

    Report Number
    2647346-2010-00360
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    April 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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: (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. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS FINDING: NO ANOMALIES FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). VISUAL ANALYSIS NOTED OUTER INSULATION COSMETIC DEPRESSION AT CONNECTOR. ELECTRICAL TESTING TO DETERMINE CONTINUITY OF THE CONDUCTOR(S) PASSED.

    Description of Event or Problem · 1

    IT WAS REPORTED APPROXIMATELY THREE YEARS AND FIVE MONTHS POST IMPLANT THE LEAD MIGRATED OUT OF THE CORONARY SINUS. CONSEQUENTLY, A REVISION PROCEDURE WAS COMPLETED: LEAD EXCISED AND REPLACED UNEVENTFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR), ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    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 65 YR Required Intervention 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD