BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1921776 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12696
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 8, 2010
    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
    MA, 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) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION WAS BREACHED CUT AND THE LEAD APPEARED TO BE DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PERSISTENT LEFT VENA CAVA AND NO RIGHT VENA CAVA. THE LEAD WAS OPENED AT IMPLANT BUT NOT USED AS IT WAS TOO SHORT FOR THE PATIENT. 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. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other