BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1923097 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06049
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 15, 2010
    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
    NY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEFIBRILLATOR HAD REACHED ELECTIVE REPLACEMENT INDICATOR AND EARLY BATTERY DEPLETION WAS SUSPECTED. THE PATIENT IS ALSO KNOWN TO HAVE CHRONIC ATRIAL FIBRILLATION. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER 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 73 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD