BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2022641 · Received March 17, 2011

    Report

    Report Number
    2649622-2011-04098
    Event Type
    Death
    Date Received
    March 17, 2011
    Date of Event
    November 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT DIED AT HOME SUDDENLY. THE INDICATION FOR THE DEFIBRILLATOR WAS VENTRICULAR FIBRILLATION ON CORONARY SPASM AND AFTER A RECOVERED SUDDEN CARDIAC ARREST. CAUSE OF DEATH IS UNKNOWN AT THIS TIME. CORRECTION MADE TO EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE ALL CONDUCTORS WERE STRETCHED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND FOUND TO HAVE NORMAL BATTERY DEPLETION. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER FOR THE (B)(4), THE MANUFACTURING DATE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) DIED. THE ICD WAS REMOVED AND INTERROGATED POST MORTEM. THERE WAS AN "EPISODE" FOUND ON THE DAY OF DEATH WITHOUT AN ELECTROGRAM. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death