BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922435 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12930
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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) NO ANOMALIES FOUND; PARTIAL LEAD, IN SEGMENTS, RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS NOTED ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND IN/ON THE HELIX MECHANISM. THE OUTER INSULATION WAS BREACHED CUT, THE HELIX WAS DISTORTED/BENT, AND THE LEAD WAS STRETCHED; LEAD DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX REMAINED EXTENDED WHEN ATTEMPTING TO REPOSITION THE LEAD DURING THE IMPLANT PROCEDURE. ATTEMPTS TO EXTRACT THE LEAD WERE UNSUCCESSFUL AND THE PHYSICIAN REMOVED IT FEMORALLY. THE LEAD WAS NOT USED. WHEN THE LEAD WAS EXTRACTED, TISSUE WAS NOTED ON THE HELIX. A DIFFERENT LEAD WAS PLACED. NO FURTHER 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 62 YR Required Intervention