BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE EPI

    MDR report key: 3070881 · Received April 22, 2013

    Report

    Report Number
    2182208-2013-01105
    Event Type
    Death
    Date Received
    April 22, 2013
    Date of Event
    February 17, 2013
    Report Date
    May 16, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE FUNERAL HOME WAS CONTACTED AND WAS UNABLE TO PROVIDE INFORMATION AND THE PATIENT'S MEDICAL DOCTORS WERE UNAWARE THE PATIENT IS DECEASED. (B)(4). CONCOMITANT PRODUCT: D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED (B)(6) 2012; 5076 IMPLANTABLE PACING LEAD IMPLANTED, (B)(6) 2012; 6932 IMPLANTABLE TACHY LEAD IMPLANTED, (B)(6) 1998.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. 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.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER DEVICE IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND WILL NOT BE RECEIVED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER DEVICE IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND WILL NOT BE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171530 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death