BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6007922 · Received October 6, 2016

    Report

    Report Number
    3008973940-2016-00754
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 23, 2016
    Report Date
    August 23, 2016
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED THERE WAS BLOOD AND TISSUE ON THE HELIX. THE ANALYST THEN SOFTENED THE BLOOD AND TISSUE BY USING ALCOHOL, THEN PERFORMED HELIX TESTS; RESULTS WAS PASSED AND THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE HELIX OF THE LOW-VOLTAGE PACING LEAD WAS UNABLE TO EXTEND OR RETRACT AND PLACEMENT DIFFICULTY WAS OBSERVED. THE LEAD WAS NOT IMPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659784 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1