BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1882291 · Received October 26, 2010

    Report

    Report Number
    2649622-2010-11972
    Event Type
    Death
    Date Received
    October 26, 2010
    Date of Event
    April 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. (B)(4) FULL LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND, PROXIMAL CONDUCTOR DISTORTED, OUTER INSULATION BREACHED CUT, AND APPARENT EXPLANT DAMAGE.(B)(4) FULL LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS FOUND DEAD IN BED ON (B)(6) 2010. THE CORONER'S REPORT STATED THAT THE PACEMAKER WAS IMPLANTED IN (B)(6) 2009; "HOWEVER, THERE WERE COMPLICATIONS WITH THE PACEMAKER REQUIRING RE-WIRING OF THE PACEMAKER ABOUT A MONTH PRIOR TO HER DEMISE. SHE HAD MENTAL ILLNESS WITH HISTORY OF SUICIDE IDEATION AND SELF HARM. RECENTLY, SHE HAD CEASED EATING AND TAKING HER MEDICATIONS". AN AUTOPSY WAS PERFORMED AND CAUSE OF DEATH WAS REPORTED AS "CORONARY ARTERY DISEASE". CORONER FURTHER REPORTED THAT THE DEATH WAS UNLIKELY RELATED TO THE DEVICE OR LEAD SYSTEM; HOWEVER, SHE NOTED THE PROBLEM WITH THE LEAD OCCURRED ABOUT MONTH PRIOR TO THE PATIENT'S DEATH. NUMEROUS ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE LEAD ISSUE WITHOUT SUCCESS.

    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