BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1802758 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08694
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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; FULL LEAD RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS PRESENT ON THE HELIX MECHANISM. THE LEAD WAS STRETCHED, WHICH OCCURRED DURING THE IMPLANT ATTEMPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT TO IMPLANT THE LEAD WAS ABANDONED, AND THE LEAD WAS "DAMAGED DURING REMOVAL DUE TO VEIN SPASM, TIGHT VASCULATURE." ANOTHER LEAD WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS 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 52 YR Required Intervention