BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1921653 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12631
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 7, 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 Location
    GA, 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): LEAD STRETCHED; THE FULL LEAD WAS RETURNED AND ANALYZED. FURTHER TESTING REVEALED INNER INSULATION KINKED BUCKED, BLOOD WAS IN/ON THE HELIX MECHANISM, AND THE LEAD WAS DAMAGED AT IMPLANT. ANALYSIS RESULTS REVEALED THE LEAD HAD BEEN STRETCHED SO THE INNER TUBING BUCKLED WHICH PREVENTED THE HELIX FROM FUNCTIONING PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT THE LEAD DISLODGED, WAS DIFFICULT TO MOVE, AND AFTER IT HAD BEEN PULLED OUT TO REGAIN SUBCLAVIAN ACCESS IT WAS REPORTED THAT THE CONDUCTOR COIL WAS DAMAGED. THE LEAD WAS NOT USED. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention