BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA CRT-D RF HV

    MDR report key: 5275092 · Received December 8, 2015

    Report

    Report Number
    2938836-2015-31989
    Event Type
    Injury
    Date Received
    December 8, 2015
    Date of Event
    November 16, 2015
    Report Date
    November 16, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF A HEADER ANOMALY WAS CONFIRMED IN THE LABORATORY. VISUAL INSPECTION NOTED THE LV IS-1 BI SEPTUM WAS DAMAGED. IT IS BELIEVED THE DAMAGED SEPTUM CAUSED THE PECTORAL STIMULATION. THE CAUSE OF THE LV IS-1 BI SEPTUM DAMAGE WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS CAUSING PECTORAL STIMULATION FOLLOWING LEAD IMPLANTATION. DAMAGED SILICON SCREW COVER AND BLOOD WAS FOUND IN THE HEADER UPON INSPECTION. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WILL BE RETURNED FOR INSPECTION. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804924 UNIFY ASSURA CRT-D RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3357-40Q A000009209

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention