BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922180 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12786
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 9, 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
    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) DISTAL CONDUCTOR WAS DISTORTED, BLOOD WAS FOUND IN OR ON THE HELIX MECHANISM AS WELL AS THE SLEEVE HEAD, THE LEAD WAS STRETCHED, AND DAMAGE WAS NOTED TO OCCUR AT IMPLANT. THE FULL LEAD WAS RETURNED AND ANALYZED. IT WAS DETERMINED THAT THE HELIX CAN NOT BE EXTENDED AND RETRACTED DUE TO DISTAL CONDUCTOR DISTORTION WITHIN THE CONNECTOR. EVALUATION SUMMARY (B)(4) DISTAL CONDUCTOR DISTORTED. (B)(4) FULL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD HELIX WAS EXTENDED 7 TIMES TO REPOSITION THE LEAD. THE HELIX PERFORMANCE WAS COMPROMISED, SO A DIFFERENT LEAD WAS 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 82 YR Other