BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3021204 · Received March 26, 2013

    Report

    Report Number
    9614453-2013-00574
    Event Type
    Death
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 28, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. ADDITIONAL INFORMATION FROM DEVICE INTERROGATION RECEIVED INDICATES THE PATIENT HAD A "POLYMORPHIC" VENTRICULAR TACHYCARDIA (VT) "WHICH HAD INTERVALS WITHIN" THE VENTRICULAR FIBRILLATION (VF) ZONE, BUT DID NOT MEET THE VF DETECTION CRITERIA; THE DEVICE HAD A PROGRAMMED VF ZONE WITH A VT MONITORING ZONE. THE CAUSE OF DEATH IS UNKNOWN. CONCOMITANT PRODUCTS: PRODUCT ID 407658, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012; PRODUCT ID 693565, IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2012; PRODUCT ID 419488, IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT PARTICIPANT IN THE (B)(6) TRIAL IS DECEASED. THE PATIENT WAS FOUND DEAD IN BED BY THE SPOUSE. FURTHER REVIEW OF THE INFORMATION INDICATES THE PATIENT DIED APPROXIMATELY EIGHT MONTHS POST DEVICE SYSTEM IMPLANT. THERE ARE NO KNOWN DEVICE SYSTEM ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124751 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D354TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death