BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 7537992 · Received May 23, 2018

    Report

    Report Number
    2182208-2018-00969
    Event Type
    Death
    Date Received
    May 23, 2018
    Date of Event
    January 1, 2014
    Report Date
    May 23, 2018
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE DATE OF DEATH WAS NOT AVAILABLE AT THE TIME OF THIS REPORT; NOR WAS IT INDICATED THAT THE DEATHS WERE LEAD-RELATED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿LONG-TERM OUTCOME OF RIGHT VENTRICULAR SEPTAL VERSUS APICAL PACING ON LEFT VENTRICULAR DYSFUNCTION PATIENTS WITH HIGH DEGREE HEART BLOCK.¿ CHINESE JOURNAL OF CARDIAC PACING AND ELECTROPHYSIOLOGY. 2014: 28( 2):128-13. DOI: 10.13333/J.CNKI.CJCPE.2014.02.009. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE LEADS. THE ARTICLE REPORTED THREE (3) PATIENT DEATHS. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD SERIAL NUMBERS. THE STATUS/LOCATION OF THE LEAD IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE CAUSE OF DEATH AND LEAD RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381127 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, PLC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Death IMPLANTABLE PULSE GENERATOR (IPG)