BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC SENTRY

    MDR report key: 2986681 · Received March 4, 2013

    Report

    Report Number
    9614453-2013-00544
    Event Type
    Death
    Date Received
    March 4, 2013
    Date of Event
    January 9, 2013
    Report Date
    March 6, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN OR EQUAL TO 210 MILLISECONDS OCCURRED BETWEEN (B)(6) 2010 AND (B)(6) 2013. A PATIENT ALERT OCCURRED FOR ATRIAL PACE LEAD IMPEDANCE LESS THAN 200 OHMS ON (B)(6) 2013. WEEKLY PACE IMPEDANCE TREND DATA SHOWS LOW IMPEDANCE FOR MAXIMUM AND MINIMUM ATRIAL PACING EQUAL TO 146 TO 110 OHMS RANGE BETWEEN (B)(6) 2011 AND (B)(6) 2013.

    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. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(4) 2013. OF NOTE, THE REPORTABLE MALFUNCTION AND/OR SERIOUS INJURY OF UNDERSENSING IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(4) 2013. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2013 AND REVEALED THAT THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERSENSING WAS PRESENT ON THE RIGHT VENTRICULAR PACE/SENSE LEAD AND THAT THE PATIENT REQUIRED EXTERNAL HIGH VOLTAGE THERAPY. DURING LEAD REVISION PROCEDURE, THE RIGHT ATRIAL LEAD WAS FOUND TO HAVE EXIT BLOCK. THE RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR PACE/SENSE LEAD WERE REPLACED. THE PATIENT WAS REPORTED TO BE IN A COMA AND SUBSEQUENTLY DIED. THE DATE OF DEATH IS NOT KNOWN. TECHNICAL REVIEW OF THE VENTRICULAR SENSE EVENTS NOTED T-WAVE OVERSENSING (TWOS) AND EPISODES OF VENTRICULAR FIBRILLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERSENSING WAS PRESENT ON THE RIGHT VENTRICULAR PACE/SENSE LEAD AND THAT THE PATIENT REQUIRED EXTERNAL HIGH VOLTAGE THERAPY. DURING LEAD REVISION PROCEDURE, THE RIGHT ATRIAL LEAD WAS FOUND TO HAVE EXIT BLOCK. THE RIGHT ATRIAL LEAD AND RIGHT VENTRICULAR PACE/SENSE LEAD WERE REPLACED. THE PATIENT WAS REPORTED TO BE IN A COMA AND SUBSEQUENTLY DIED. THE DATE OF DEATH IS NOT KNOWN. TECHNICAL REVIEW OF THE VENTRICULAR SENSED EVENTS NOTED T-WAVE OVERSENSING (TWOS) AND EPISODES OF VENTRICULAR FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90589 INSYNC SENTRY DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND 7298

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death| H| R 6935 IMPLANTABLE TACHY LEAD