BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2130666 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03369
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 17, 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
    PA, 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 PATIENT WAS PULLING A TRASH CAN UP A SMALL INCLINE WHEN THE PATIENT EXPERIENCED SYMPTOMS OF DIZZINESS AND A SLOW HEART RATE. IT WAS ALSO REPORTED THAT THERE WAS T-WAVE OVERSENSING NOTED WHICH AFFECTED THE V-A TIMING CYCLE, THUS LOWERING THE PATIENT'S HEART RATE BELOW THE PROGRAMMED LOWER LIMIT. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE 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 48 YR Life Threatening| R (B)(4) IMPLANTABLE PACING LEAD| 4592 COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD