BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2526006 · Received April 10, 2012

    Report

    Report Number
    6000144-2012-01731
    Event Type
    Injury
    Date Received
    April 10, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ACTUAL LONGEVITY IS LESS THAN 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

    THE BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (BI-V ICD) WAS RETURNED TO THE MANUFACTURER WITH NO REASON FOR REPLACEMENT. THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. FOLLOW UP DETERMINED THAT THE BIV ICD WAS EXPLANTED AND REPLACED FOR DEVICE CHANGE TO A BI-VENTRICULAR IMPLANTABLE PULSE GENERATOR. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD