BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVA

    MDR report key: 6006626 · Received October 6, 2016

    Report

    Report Number
    9614453-2016-06097
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 29, 2016
    Report Date
    October 13, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD IMPEDANCE ALERT TRIGGERED AND A X-RAY OF THE PATIENT'S THORAX NOTED THE RV PACE/SENSE LEAD PIN WAS NOT INSERTED ENOUGH INTO THE RV PORT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DURING RE-OPERATION, IT WAS NOT POSSIBLE TO PLACE THE LEAD PIN FAR ENOUGH INTO THE HEADER OF THE ICD AND PIN MOVEMENT WAS OBSERVED IN THE HEADER. IT WAS DECIDED TO REPLACE THE ICD DUE TO A SUSPECTED SETSCREW ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658138 BRAVA DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBC2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R 6931 LEAD