BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1813578 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08887
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    February 19, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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: (B)(4): NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THE ATRIAL LEAD HAS BEEN ADDED TO THE EVENT. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    HIGH THRESHOLD WAS REPORTED. PATIENT HAD EXPERIENCED A FALL IN LATE (B)(6) 2008. PATIENT WAS ALSO REPORTED AS A POSSIBLE TWIDDLER. THE LEAD WAS REPLACED. IT WAS ALSO REPORTED THAT THERE WERE HIGH THRESHOLD ON THE ATRIAL LEAD, AND THE LEAD WAS PULLED BACK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED PATIENT LAST SEEN BY PHYSICIAN (B)(6) 2009, DEVICE CHECK COMPLETED, AND EVERYTHING APPEARED FINE. THE PATIENT "WENT INTO CARDIAC ARREST AT HOME AND DIED IN THE ER ON (B)(6) 2009."

    Description of Event or Problem · 1

    HIGH THRESHOLD WAS REPORTED. PATIENT HAD EXPERIENCED A FALL IN LATE (B)(6) 2008. PATIENT WAS ALSO REPORTED AS A POSSIBLE TWIDDLER. THE LEAD WAS REPLACED. IT WAS ALSO REPORTED THAT THERE WERE HIGH THRESHOLD ON THE ATRIAL LEAD, AND THE LEAD WAS PULLED BACK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| R (B)(4) IMPLANTABLE PULSE GENERATOR