BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990203 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02262
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 1, 2014
    Report Date
    February 5, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD PERFORATION AS ASSESSED BY MULTIPLANAR REFORMATTED ECG-GATED CARDIAC COMPUTED TOMOGRAPHY AND CLINICAL CORRELATES. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2014;37(5):537-545. (B)(4).

    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6). REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.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. REFERENCED ARTICLE: PACING AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD PERFORATION AS ASSESSED BY MULTIPLANAR REFORMATTED ECG-GATED CARDIAC COMPUTED TOMOGRAPHY AND CLINICAL CORRELATES. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2014;37(5):537-545. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. THE ARTICLE INDICATED THAT THERE WAS LEAD PERFORATION. ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR INDICATED THAT THE LEAD WAS RE-POSITIONED AND REMAINS IN USE. THE AUTHOR ALSO STATED THAT IT WAS MORE RELATED TO THE "IMPLANTED TECHNIQUE" RATHER THAN THE LEAD ITSELF.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. THE ARTICLE INDICATED THAT THERE WAS LEAD PERFORATION. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463502 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R