BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA CRT-D

    MDR report key: 2933916 · Received January 29, 2013

    Report

    Report Number
    9614453-2013-00027
    Event Type
    Death
    Date Received
    January 29, 2013
    Date of Event
    March 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED. IT WAS FURTHER REPORTED THAT THE PATIENT DIED IN A 'CPR SITUATION.' ADDITIONAL INFORMATION NOTED THAT THE PHYSICIAN TESTED THE DEVICE FUNCTION AT THE EMERGENCY EVENT AND FOUND A CARDIAC DEATH BUT NO HINT OF VENTRICULAR FIBRILLATION, VENTRICULAR TACHYCARDIA OR ANY OTHER DEVICE MALFUNCTION WAS NOTED. THE CAUSE OF DEATH AND ADDITIONAL CIRCUMSTANCES OF DEATH HAVE BEEN REQUESTED AND WILL NOT BE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38895 PROTECTA CRT-D NIK IPG MFG SWITZERLAND D364TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 Death