BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2203467 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12118
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. EVALUATION SUMMARY: (B)(4): THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD PACING THRESHOLD WAS MORE THAN 8 V. THE LEAD WAS NOT USED AND A SECOND LEAD WAS ATTEMPTED. THE PACING THRESHOLD OF THE SECOND LEAD WAS MORE THAN 8 V ALSO, HOWEVER THE LEAD REMAINS IN USE. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other