BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1720357 · Received June 11, 2010

    Report

    Report Number
    6000144-2010-02977
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    March 29, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    Z-0126-2010
    Adverse Event
    Yes
    Product Problem
    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. TEXT CONTINUED FROM PATIENT EVENT DESCRIPTION - THE PATIENT RECOVERED FULLY AND WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT APPROXIMATELY 8 MONTHS LATER, THE PATIENT HAD ONE ARRHYTHMIA THAT WAS SUCCESSFULLY TREATED, BUT PATIENT WAS LATER FOUND UNRESPONSIVE ON THE COUCH. PATIENT WAS REPORTED TO BE "BRAIN DEAD." REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED 13 DAYS LATER. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. 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. THAT DATA SHOWED INTERFERENCE/NOISE AND VENTRICULAR OVERSENSING. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 94 AND ALL COUNTS OCCURED OVER FIVE DAYS PREVIOUS TO INTERROGATION. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTED DATE OF DEATH. THE PATIENT RECOVERED FULLY AND WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT APPROXIMATELY 8 MONTHS LATER, THE PATIENT HAD ONE ARRHYTHMIA THAT WAS SUCCESSFULLY TREATED, BUT PATIENT WAS LATER FOUND UNRESPONSIVE ON THE COUCH. PATIENT WAS REPORTED TO BE "BRAIN DEAD." REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED. ADDITIONAL INFORMATION FROM PHYSICIAN REPORTED PATIENT HAD CEREBRAL HEMORRHAGE AND WAS REMOVED FROM LIFE SUPPORT DUE TO SEVERE DIFFUSE ANOXIC ENCEPHALOPATHY WITH EEG SHOWING ABSENCE OF REACTIVITY, POST VENTRICULAR FIBRILLATION ARREST, RESPIRATORY ARREST. THERE WAS NO ALLEGATION OF ANY DEVICE MALFUNCTION OR FAILURE. 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. THAT DATA SHOWED INTERFERENCE/NOISE AND VENTRICULAR OVERSENSING. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 94 AND ALL COUNTS OCCURED OVER FIVE DAYS PREVIOUS TO INTERROGATION. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PATIENT RECOVERED FULLY AND WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. 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. THAT DATA SHOWED INTERFERENCE/NOISE AND VENTRICULAR OVERSENSING. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 94 AND ALL COUNTS OCCURED OVER FIVE DAYS PREVIOUS TO INTERROGATION. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ARRHYTHMIAS IN THE CAR WHILE DRIVING TO THE ER AND NEVER RECEIVED THERAPY BECAUSE THE TREATMENT HAD BEEN ABORTED. THE DEVICE "WAS PACING AT THE UPPER SENSING RATE=130 BPM, WHICH MAY HAVE COMPROMISED DETECTION. ATRIAL UNDERSENSING AND ACTIVITY PACING CAUSED VENTRICULAR SAFETY PACING AS SEVERAL OF THE FIBRILLATION SENSED EVENTS TO BE SENSED AS CROSS-TALK." IT WAS ALSO REPORTED THE VENTRICULAR SENSED INTERVALS WERE AS LONG AS 360 MS. SHORT INTERVALS BEFORE FIBRILLATION DETECTION DISABLED ANTI-TACHYCARDIA PACING DURING CHARGE WHICH CAUSED THE THERAPY TO ABORT DURING THE CHARGE. SOME OF THE INTERVALS WERE AT 190 MS WHICH WERE TOO SHORT TO PROGRAM AROUND. ADDITIONALLY, THE HOSPITAL PERSONNEL TRIED TO RESUSCITATE THE PATIENT, BUT HE WAS PRONOUNCED DEAD. AN HOUR LATER, FAMILY WENT INTO HIS ROOM TO SAY GOODBYE AND DISCOVERED MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ARRHYTHMIAS IN THE CAR WHILE DRIVING TO THE ER. THE PATIENT NEVER RECEIVED THERAPY BECAUSE THE TREATMENT ABORTED IN VF EPISODE #24. THE DEVICE "WAS PACING AT THE UPPER SENSING RATE=130 BPM, WHICH MAY HAVE COMPROMISED DETECTION. ATRIAL UNDERSENSING AND ACTIVITY PACING CAUSED VENTRICULAR SAFETY PACING AS SEVERAL OF THE FIBRILLATION SENSED EVENTS TO BE SENSED AS CROSS-TALK." IT WAS ALSO REPORTED THE VENTRICULAR SENSED INTERVALS WERE AS LONG AS 360 MS. SHORT INTERVALS BEFORE FIBRILLATION DETECTION DISABLED ANTI-TACHYCARDIA PACING DURING CHARGE WHICH CAUSED THE THERAPY TO ABORT DURING THE CHARGE. SOME OF THE INTERVALS WERE AT 190 MS WHICH WERE TOO SHORT TO PROGRAM AROUND. ADDITIONALLY, THE HOSPITAL PERSONNEL TRIED TO RESUSCITATE THE PATIENT, BUT HE WAS PRONOUNCED DEAD. AN HOUR LATER, FAMILY WENT INTO HIS ROOM AND DISCOVERED MOVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| H| L| R 4193 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD