BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2012403 · Received March 9, 2011

    Report

    Report Number
    2647346-2011-00234
    Event Type
    Death
    Date Received
    March 9, 2011
    Date of Event
    October 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION VIA FOLLOW-UP WAS OBTAINED AND INCLUDES THE FOLLOWING: THE PATIENT REPORTED FEELING MODERATE IMPROVEMENT AT ONE MONTH FOLLOW-UP, AND MILD IMPROVEMENT AT THREE MONTH FOLLOW-UP. STARTING MID-DECEMBER AN INCREASE IN HEART RATE, IN OPTI VOL FLUID INDEX, AND AN INCREASE IN PREMATURE VENTRICULAR CONTRACTIONS (PVC) IN JANUARY WERE ALL OBSERVED. SHOULDER SURGERY 2 DAYS PRIOR TO THE DEATH. NON SUSTAINED VENTRICULAR TACHYCARDIA'S, VERY HIGH PVC COUNT WERE OBSERVED IN JANUARY (142.7 PER HOUR). ON THE DATE OF DEATH THE PATIENT EXPERIENCED SLOW VENTRICULAR TACHYCARDIA (MEDIAN RATE OF 194 BPM) RECORDED BY THE DEVICE, SLOWED BY ANTI TACHY PACING INTO NON-DETECTION ZONE AND COUNTED AS SUCCESSFUL. NO EVIDENCE OF OTHER EPISODES. NO INFORMATION ON HOW THE VENTRICULAR TACHYCARDIA INITIATED OR WHETHER IT WAS THE PRIMARY CAUSE OF DEATH. PER THE POST-MARKET STUDY SITE THE RELATEDNESS OF THE PATIENT'S DEATH AS "UNKNOWN" TO THE DEVICE, LEADS, AND INVESTIGATIONAL ALGORITHM. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS CAUSING DIAPHRAGMATIC STIMULATION. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT DIED. THE CAUSE OF DEATH IS "NOT KNOWN". THE PATIENT UNDERWENT AN ELECTIVE SURGERY ON THEIR SHOULDER TWO DAYS PRIOR TO DEATH AND WENT HOME THE NEXT DAY. ON THE DAY OF DEATH THE PATIENT WAS AT HOME BEGAN TO FEEL UNWELL. THE SPOUSE REPORTED THAT THE PATIENT BEGAN GETTING RESTLESS AND WAS UP AND DOWN AND STATED THEY FELT THEIR HEART THUMPING. THE PATIENT TOOK A PAIN PILL AND WENT TO BED. WHEN THEY AWOKE A FEW HOURS LATER THEY WERE VERY RESTLESS AND BEGAN TO DETERIORATE, EMERGENCY MEDICAL SERVICES WAS CALLED, AND RESUSCITATION WAS ATTEMPTED, BUT UNSUCCESSFUL. THE PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) COMPETITOR IMPLANTABLE TACHY LEAD