BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1924496 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13585
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    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): THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON/IN THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT OF THE RIGHT VENTRICULAR LEAD, THE HELIX EXTENSION WAS INCONSISTENT. R-WAVE AMPLITUDE IN THE PATIENT WOULD DECAY FROM 8-10 MV TO 2-3 MV AT BOTH THE APEX AND SEPTAL WALL LOCATIONS. IMPEDANCE AND THRESHOLDS WERE GOOD. A DIFFERENT LEAD WAS SUCCESSFULLY IMPLANTED. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other