BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1924995 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13661
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    August 31, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY : (B)(4): A PARTIAL LEAD [DISTAL SEGMENT] WAS RETURNED AND ANALYZED. PRIMARILY ANALYSIS REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT WAS INAPPROPRIATE FOR THE PATIENT ANATOMY AND FAILED TO FIXATE PROPERLY. THE LEAD WAS NOT IMPLANTED; ANOTHER LEAD WAS USED. 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 SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other