BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIB EPI PATCH

    MDR report key: 3854502 · Received June 6, 2014

    Report

    Report Number
    3002807561-2014-00005
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    July 6, 2011
    Report Date
    August 27, 2014
    Manufacturer
    EOC HEERLEN DISTRIBUTION CTR
    Product Code
    LWS
    PMA / PMN Number
    P900061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED AND THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 7232CX ICD, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY SIX YEARS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. IT WAS FURTHER REPORTED THAT THE PATIENT WAS AT HOME WITH FAMILY WHEN RECEIVED HIGH VOLTAGE THERAPY. THE PATIENT IS NOTED TO HAVE DIED ¿RIGHT AFTER¿. EMERGENCY SERVICES HAD BEEN CONTACTED AND ATTEMPTED TO RESUSCITATE THE PATIENT BUT WAS UNSUCCESSFUL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN NOTIFIED THAT REPLACEMENT OF THE ICD MAY BE NECESSARY. THE REASON FOR REPLACEMENT IS UNKNOWN AND WAS NOT EXPLAINED TO THE FAMILY. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS BY THE FAMILY AND NO ADDITIONAL INFORMATION WAS AVAILABLE FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331895 DEFIB EPI PATCH DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS EOC HEERLEN DISTRIBUTION CTR 6721S-50

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 4968-60 LEAD