BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2813540 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06595
    Event Type
    Injury
    Date Received
    October 31, 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
    MA, 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): UPON ANALYSIS, NORMAL BATTERY DEPLETION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY HAVE REACHED THE ELECTIVE REPLACEMENT INDICATOR [ERI] PREMATURELY. IT WAS ALSO REPORTED THAT A PATIENT ALERT WAS TRIGGERED. THE DEVICE WAS EXPLANTED AND REPLACED. 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 75 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD