BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1670595 · Received April 30, 2010

    Report

    Report Number
    2647346-2010-00148
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    April 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED THE EVENING OF (B) (6) 2010 AND HAD VF (VENTRICULAR FIBRILLATION) EPISODES BETWEEN 21:49 AND 22:01 ON (B) (6) 2010. IN 2 OF THE EPISODES, THE PATIENT RECEIVED SHOCKS THAT TERMINATED THE RHYTHMS. REVIEW OF THE EPISODES BY MANUFACTURER'S TECHNICAL SERVICE REPORTED WHAT APPEARED TO BE INSTANCES OF UNDERSENSING "WHERE THE THERAPY WOULD HAVE BEEN DELAYED" AND "EPISODES WHERE THE RHYTHM APPEARS SO FAST THAT THERE MAY BE OVERSENSING." "OVERSENSING DID NOT CAUSE THE PATIENT TO BE SHOCKED INAPPROPRIATELY." THERE IS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED THE EVENING OF (B)(6)2010 AND HAD VF (VENTRICULAR FIBRILLATION) EPISODES BETWEEN 21:49 AND 22:01 ON (B)(6)2010. IN 2 OF THE EPISODES, THE PATIENT RECEIVED SHOCKS THAT TERMINATED THE RHYTHMS. REVIEW OF THE EPISODES BY MANUFACTURER'S TECHNICAL SERVICE REPORTED WHAT APPEARED TO BE INSTANCES OF UNDERSENSING "WHERE THE THERAPY WOULD HAVE BEEN DELAYED" AND "EPISODES WHERE THE RHYTHM APPEARS SO FAST THAT THERE MAY BE OVERSENSING." "OVERSENSING DID NOT CAUSE THE PATIENT TO BE SHOCKED INAPPROPRIATELY." THERE IS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP WITH THE PHYSICIAN REPORTED THE CAUSE OF DEATH TO BE SUDDEN CARDIAC DEATH.

    Description of Event or Problem · 1

    (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD