BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC SENTRY

    MDR report key: 4101244 · Received September 19, 2014

    Report

    Report Number
    2182208-2014-02488
    Event Type
    Death
    Date Received
    September 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF ANY SPECIFICS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: CONTRAST-INDUCED ACUTE KIDNEY INJURY IN PATIENTS UNDERGOING CARDIAC RESYNCHRONIZATION THERAPY - INCIDENCE AND PROGNOSTIC IMPORTANCE. SUB-ANALYSIS OF DATA FROM RANDOMIZED TRUST CRT TRIAL. J. INTERVENT. CARD. ELECTROPHYSIOL. 2014;40(1):1-8. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS MODEL OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. SERIOUS ADVERSE EVENTS (SAES)AND/OR DEATH WERE REFERENCED IN THE ARTICLE, WITH NO SPECIFIC DEVICE SERIAL NUMBER CORRELATION. THE STATUS OF THE ICD IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582302 INSYNC SENTRY DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC, INC. 7298

    Patients

    Seq Age Sex Outcome Treatment
    1 Death