BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1791800 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06951
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    December 2, 2008
    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
    HEALTH PROFESSIONAL

    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) NO ANOMALIES FOUND. THE FULL LEAD WAS RETURNED. CUTS WERE EVIDENT THROUGH THE OUTER INSULATION MATERIAL AT 25 CM AND 26 CM. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. THE FULL LEAD WAS RETURNED. CUTS WERE EVIDENT THROUGH THE OUTER INSULATION MATERIAL AT 18 CM AND 19 CM. EVALUATION SUMMARY (B)(4) (B)(4) FULL LEAD (B)(4) (B)(4) FULL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, LEAD MODEL 4076/(B)(4) WAS REMOVED DUE TO NO CAPTURE AND OVERSENSING. IN ADDITION LEAD MODEL 4076/(B)(4) WAS REMOVED DUE TO HIGH IMPEDANCE. THE DEVICE WAS NOT IMPLANTED. 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 Required Intervention