BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1813554 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08904
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    August 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED). FULL LEAD RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED). FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, GROMMET DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 17 DAYS FOLLOWING DEVICE IMPLANT, THE PATIENT EXPERIENCED SUSTAINED VENTRICULAR TACHYCARDIA AND THE DEVICE SYSTEM DID NOT PERFORM DEFIBRILLATION TREATMENT. "THE CAUSE OF THE PHEMOMENON WAS UNDERDETECT SENSING." PACING FAILURE WAS ALSO REPORTED. "THE SUSTAINED VENTRICULAR TACHYCARDIA WAS CURED ONCE, BUT THE PATIENT EXPIRED LATER. THE CAUSE OF DEATH WAS CONCLUDED TO BE THE ELECTRICAL STORM." ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 17 DAYS FOLLOWING DEVICE IMPLANT, THE PATIENT EXPERIENCED SUSTAINED VENTRICULAR TACHYCARDIA AND THAT THE DEVICE SYSTEM DID NOT PERFORM DEFIBRILLATION TREATMENT. "THE CAUSE OF THE PHENOMENON WAS UNDERDETECT SENSING." PACING FAILURE WAS ALSO REPORTED. "THE SUSTAINED VENTRICULAR TACHYCARDIA WAS CURED ONCE, BUT THE PATIENT EXPIRED LATER. THE CAUSE OF DEATH WAS CONCLUDED TO BE THE ELECTRICAL STORM." FOLLOW UP REVEALED THERE WERE NO DEVICE ALLEGATIONS BY THE HEALTH CARE PROFESSIONAL RELATED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 17 DAYS FOLLOWING DEVICE IMPLANT, THE PATIENT EXPERIENCED SUSTAINED VENTRICULAR TACHYCARDIA AND THAT THE DEVICE SYSTEM DID NOT PERFORM DEFIBRILLATION TREATMENT. "THE CAUSE OF THE PHENOMENON WAS UNDERDETECT SENSING." PACING FAILURE WAS ALSO REPORTED. "THE SUSTAINED VENTRICULAR TACHYCARDIA WAS CURED ONCE, BUT THE PATIENT EXPIRED LATER. THE CAUSE OF DEATH WAS CONCLUDED TO BE THE ELECTRICAL STORM." FOLLOW UP REVEALED THERE WERE NO DEVICE ALLEGATIONS BY THE HEALTH CARE PROFESSIONAL RELATED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death