BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791060 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15397
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 21, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX WAS DISTORTED/BENT. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN/ON THE HELIX MECHANISM, DAMAGED GUIDETOOTH, TISSUE ON THE HELIX AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX FULLY EXTENDED, DISTORTED/BENT AND STRETCHED. HOWEVER THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED BUT OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THERE WAS PLACEMENT DIFFICULTY WITH THE LEAD. WHEN THE LEAD WAS IN THE PATIENT, THE LEAD HELIX SEEMED TO DEPLOY ON ITS OWN OR IT WAS ALREADY OUT (ALTHOUGH THIS WAS NOT OBSERVED BEFORE PLACING THE LEAD IN THE SHEATH). THE HELIX SEEMED TO CATCH ON A CHRONIC LEAD AND WHEN INITIAL ATTEMPTS WERE MADE TO BACK THE LEAD OUT IT GOT CAUGHT ON THE TRICUSPID VALVE. THE LEAD WAS REMOVED AND THERE APPEARED TO BE SOME TISSUE ON THE HELIX. A NEW LEAD WAS 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 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other