BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1071847 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-04016
    Event Type
    Death
    Date Received
    July 10, 2008
    Date of Event
    March 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. EVALUATION SUMMARY: NO ANOMALIES WERE FOUND. OTHER: IT WAS REPORTED THAT THE DECEDENT'S DEVICE SYSTEM WAS EXPLANTED, DUE TO INFECTION IN 2008. ACCORDING TO THE PATIENT'S DAUGHTER "SHE HAD ONE OF THE RECALLED LEADS AND THEY PUT A THING DOWN HER THROAT INTO HER HEART AND FOUND AN INFECTION THAT WAS LEAKING INTO HER BODY. THEY COULDN'T GET RID OF IT." SHE FURTHER ALLEGED THAT THE LEADS "WERE WHY SHE DIED". THE DECEDENT DIED TWO MONTHS POST EXPLANT. THERE IS NO ALLEGATION BY A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. CAUSE OF DEATH WAS REQUESTED, BUT NOT RECEIVED. ATTEMPTS FOR FOLLOW-UP INFORMATION HAVE BEEN UNSUCCESSFUL. PATIENT'S DAUGHTER, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DECEDENT'S DEVICE SYSTEM WAS EXPLANTED, DUE TO INFECTION IN 2008. ACCORDING TO THE PATIENT'S DAUGHTER "SHE HAD ONE OF THE RECALLED LEADS AND THEY PUT A THING DOWN HER THROAT INTO HER HEART AND FOUND AN INFECTION THAT WAS LEAKING INTO HER BODY. THEY COULDN'T GET RID OF IT." SHE FURTHER ALLEGED THAT THE LEADS "WERE WHY SHE DIED". THE DECEDENT DIED TWO MONTHS POST EXPLANT. THERE IS NO ALLEGATION BY A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. CAUSE OF DEATH WAS REQUESTED, BUT NOT RECEIVED. ATTEMPTS FOR FOLLOW-UP INFORMATION HAVE BEEN UNSUCCESSFUL.

    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| O| R