BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2112592 · Received June 3, 2011

    Report

    Report Number
    2649622-2011-07718
    Event Type
    Death
    Date Received
    June 3, 2011
    Date of Event
    March 25, 2011
    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
    WA, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SENSING INQUIRY WAS MADE REGARDING THE RIGHT VENTRICULAR LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE IMPLANTABLE CARDIAC DEFIBRILATOR SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH SHOWED THAT THE PATIENT HAD EXPIRED 3 MONTHS AFTER THE INQUIRY ABOUT SENSING ISSUES. THE CAUSE OF DEATH WAS AN ARRYTHMIA SECONDARY TO ISCHEMIC CARDIOMYOPATHY. NO FURTHER COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE AGAINST THE SYSTEM OR ANY OF THE INDIVIDUAL COMPONENTS.

    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 82 YR Death| O 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB