BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2200693 · Received August 11, 2011

    Report

    Report Number
    2647346-2011-01002
    Event Type
    Injury
    Date Received
    August 11, 2011
    Report Date
    September 19, 2019
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #002 SHOULD HAVE BEEN SEQUENCED #001, SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED PROGRESSIVELY WORSENING T-WAVE OVERSENSING. THE RV LEAD REMAINS IMPLANTED, BUT THE PHYSICIAN OPTED TO PACE WITH THE LEFT VENTRICULAR LEAD ONLY AT THIS TIME. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING DIZZY SPELLS AND PERIODS OF ASYSTOLE WERE REVEALED ON A HOLTER MONITOR. THE ALL CAPTURE MANAGEMENT TESTING WAS TURNED OFF. THE DEVICE AND LEAD REMAIN IN USE. 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 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MDT PUERTO RICO OPERATIONS CO, MED REL D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Life Threatening| R BFJ24D COMPETITOR IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD