BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3153026 · Received June 8, 2013

    Report

    Report Number
    3008973940-2013-00063
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE OUTERINSULATION OF THE LEAD WAS EXTRINSICALLY CUT BUT NOT BREACHED AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST COMMENTED THAT ELECTRICAL AND CROSS CONTINUITY TEST AND HELIX LENGTH RESULTS WERE WITHIN SPECIFICATION. AND THERE WAS NO INSULATIONS BREACHED WAS OBSERVED.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT, THAT THE INITIAL CHECK OF A TEMPORARY LEAD HAD NORMAL R-WAVE, IMPEDANCE AND THRESHOLD MEASUREMENTS BUT WHEN THE DEVICE WAS CONNECTED TO THE LEAD THERE WAS NO PACING. IT WAS NOTED THAT SCREENING SHOWED THE LEAD HAD NOT MOVED, BUT A RECHECK OF THE LEAD HAD AN IMPEDANCE OF 1600 OHMS AND A THRESHOLD OF 4 VOLTS. THE LEAD WAS REPOSITIONED BUT THE ELECTRICAL MEASUREMENTS COULD NOT BE RESOLVED. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD WHICH HAD FINE ELECTRICAL PARAMETERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254474 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1