BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 4937972 · Received July 24, 2015

    Report

    Report Number
    1000165971-2015-00461
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NIK
    PMA / PMN Number
    PP060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    REPORTEDLY, UNEXPLAINED NOISE WAS OBSERVED ON THE VENTRICULAR EGM WITH 胒OSS-TALK頏N THE ATRIAL EGM CHANNEL. THE SUBJECT ICD WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, UNEXPLAINED NOISE WAS OBSERVED ON THE VENTRICULAR EGM WITH ¿CROSS-TALK¿ ON THE ATRIAL EGM CHANNEL. THE SUBJECT ICD WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, UNEXPLAINED NOISE WAS OBSERVED ON THE VENTRICULAR EGM WITH 'CROSS-TALK' ON THE ATRIAL EGM CHANNEL. THE SUBJECT ICD WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, UNEXPLAINED NOISE WAS OBSERVED ON THE VENTRICULAR EGM WITH 'CROSS-TALK' ON THE ATRIAL EGM CHANNEL. THE SUBJECT ICD WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483748 PARADYM DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D) NIK SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF CRT-D 9750 2657

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention