BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1874512 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11427
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    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 NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. ( DATE OF DEATH TO NOT APPLICABLE, PATIENT OUTCOME CHECKED HOSPITALIZATION). EVALUATION SUMMARY; (B)(4) THE PROXIMAL SEGMENT WAS RETURNED. THE ANALYSIS REVEALED THAT THE OUTER TUBING OVERLAY WAS CUT RESULTING IN A BREACH. THERE WAS BLOOD/BODY FLUID ON THE OUTER OVERLAY AND THERE WAS COSMETIC DEPRESSION. THE TUBING INNER AND OUTER WAS KINKED/BUCKLED. THE OUTER OVERLAY WAS BREACHED DUE TO ENVIRONMENTAL STRESS CRACKS AND MELTED IN VARIOUS LOCATIONS. THE DISTAL CONDUCTOR WAS DISTORTED. THERE WAS APPARENT EXPLANT DAMGE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED INSULATION PROBLEMS AND CAPTURE PROBLEMS, AND THAT THE ATRIAL LEAD HAD "FARFIELD" (R-WAVE OVERSENSING). THE PHYSICIAN INTENDED TO EXTRACT THE RV LEAD AND REPOSITION THE ATRIAL LEAD. HOWEVER, THE ATRIAL LEAD COULD NOT BE FIXATED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. THE RV LEAD BROKE INTO TWO PARTS AND ONLY THE PROXIMAL PORTION COULD BE RETRIEVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R