BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRAVA

    MDR report key: 3921921 · Received July 9, 2014

    Report

    Report Number
    9614453-2014-01533
    Event Type
    Death
    Date Received
    July 9, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 18, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    NO EVAL. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 6935M62 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY THREE WEEKS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE SYSTEM. THE PATIENT IS REPORTED TO HAVE PASSED AWAY AT HOME. PHYSICIAN REVIEW OF THE RECORDED EPISODES DID NOT SHOW ANY FAILURE TO TREAT; HOWEVER, THREE EPISODES WERE OVERWRITTEN BUT SUBSEQUENT EPISODES. THE INITIAL EPISODE REVIEWED WITH ELECTROGRAM NOTED THE PATIENT HAD NON-SUSTAINED VENTRICULAR FIBRILLATION (VF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401754 BRAVA DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBC2D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death 4968-60 LEAD