BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2131892 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03502
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PATIENT HAD A HIGH HEART RATE WHILE SITTING QUIETLY. THE PHYSICIAN THOUGHT IT MAY HAVE BEEN DUE TO THE RATE RESPONSE FEATURE. THE PATIENT'S INTRINSIC RHYTHM HAD FREQUENT PREMATURE ATRIAL CONTRACTIONS. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 6935 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD