BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREVIA 7 HF-T QP DF4 IS4

    MDR report key: 6158001 · Received December 9, 2016

    Report

    Report Number
    1028232-2016-04906
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 28, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    WE RECEIVED YOUR EVENT DESCRIPTION FOR THE ABOVE MENTIONED DEVICE AND WOULD LIKE TO THANK YOU FOR SUPPORTING OUR POST-MARKET SURVEILLANCE. AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF SHORTNESS OF BREATH WHEN PATIENT IS LYING DOWN. DENIES CHEST PAIN AND PALPITATIONS BUT REPORTED A FEELING IN HIS CHEST. PATIENT ALSO REPORTED A COUGH. HE DENIED FEVER AND CHILLS. PATIENT WAS ADMITTED FOR OBSERVATION. CT NEGATIVE FOR PULMONARY EMBOLISM. TROPONIN NEGATIVE TIMES 2. BNP IMPROVED SINCE DATE OF IMPLANT. NO EVENTS ON DEVICE INTERROGATION. A SHORT RUN OF NON SUSTAINED VENTRICULAR TACHYCARDIA WAS NOTED ON TELEMETRY. UPON DISCHARGE, PATIENT WAS TRANSFERRED TO SUB ACUTE REHAB. ALL AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS ACTIVELY IMPLANTED AND NO CHANGES WERE MADE TO THIS CRT-D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809797 ITREVIA 7 HF-T QP DF4 IS4 CRT-D NIK BIOTRONIK SE & CO. KG 401662

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other