BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2881627 · Received December 20, 2012

    Report

    Report Number
    2182863-2012-00099
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 28, 2012
    Manufacturer
    SORIN CRM
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2012.THE ANALYSIS ON THIS DEVICE IS PENDING.

    Description of Event or Problem · 1

    AFTER A FEW WEEKS OF IMPLANTATION, THIS ICD WAS EXPLANTED DUE TO A HEMATOMA WITH POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK SORIN CRM 9550

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R