BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922649 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13016
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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) THE FULL LEAD WAS RETURNED, ANALYZED AND THE LEAD WAS STRETCHED. IT WAS NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX FULLY RETRACTED AND THE DISTAL CONDUCTOR DISTORTED WITHIN THE CONNECTOR. THE DISTAL CONDUCTOR HAS BEEN OVER-RETRACTED. THE STRETCHING OF THE LEAD CAUSED THE INNER TUBING TO BUCKLE PREVENTING PROPER TORQUE TRANSFER WHEN TURNING THE IS-1 PIN. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT FOR A PACEMAKER SYSTEM, THE SCREW DID NOT COME OUT OF THE LEAD BODY AFTER IT WAS PLACED IN THE RIGHT VENTRICLE. THE LEAD WAS REMOVED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other