BEUDAMED
    FDA Adverse Event Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1071925 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03762
    Date Received
    July 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) ALL CONDUCTORS FRACTURED; PROXIMAL SEGMENT WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS OBSERVED ON ALL CONDUCTORS (NOT OBSTRUCTED). COSMETIC DEPRESSION ON OUTER INSULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD FRACTURE UNDER THE CLAVICLE AREA NOTICED ON AN X-RAY AT A REGULAR FOLLOW-UP. IT WAS ALSO REPORTED THAT THERE WAS HIGH IMPEDANCE GREATER THAN 9999 OHMS AND PACING FAILURE. THE LEAD POLARITY WAS CHANGED FROM BIPOLAR TO UNIPOLAR. THE LEAD WAS LATER EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5054 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R