BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861658 · Received June 10, 2014

    Report

    Report Number
    3008973940-2014-00214
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 30, 2014
    Report Date
    March 21, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OUT OF RANGE MEASUREMENTS WERE OBSERVED ON THE IMPLANTABLE PACING LEAD DURING THE SIX-WEEK POST-OP FOLLOW-UP VISIT. LEAD PERFORATION INTO THE PERICARDIUM WAS CONCLUDED AND NO PRODUCT PERFORMANCE ISSUES WERE ALLEGED. THE PATIENT WAS SENT TO THE HOSPITAL FOR LEAD REVISION WHEREIN THE LEAD WAS EXTRACTED AND REPLACED. DURING THE LEAD REPLACEMENT PROCEDURE, A SMALL PERICARDIAL EFFUSION WAS NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339698 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Hospitalization| L| R