BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1926002 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14126
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 26, 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
    IS
    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) NO ANOMALIES WERE FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED AND THERE WAS DAMAGE FROM IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, AFTER THE VENTRICULAR LEAD WENT THROUGH THE RIGHT VENTRICULAR OUTFLOW TRACT, ITS TIP KEPT MOVING UPWARD AND DID NOT RESPOND TO THE STYLET AT HAND. THE LEAD WAS NOT USED, AND REPLACED WITH A NEW ONE. 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 86 YR Other