BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2951971 · Received February 9, 2013

    Report

    Report Number
    3008973940-2013-00006
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    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). EVALUATION SUMMARY: (B)(4): NO ANOMALIES WERE FOUND, HOWEVER BLOOD WAS NOTED ON THE DISTAL ELECTRODE; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEAD, DIFFICULTIES WERE EXPERIENCED WITH EXTENDING THE HELIX INSIDE THE PAT IENT. PRIOR TO IMPLANT THE HELIX MECHANISM EXTENDED WITHOUT PROBLEMS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEAD, DIFFICULTIES WERE EXPERIENCED WITH EXTENDING THE HELIX INSIDE THE PATIENT. PRIOR TO IMPLANT THE HELIX MECHANISM EXTENDED WITHOUT PROBLEMS. THE LEAD WAS EXPLANTED 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
    56786 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1