BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1921540 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12581
    Event Type
    Malfunction
    Date Received
    December 13, 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
    MS, 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 ANALYST NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED. THE DISTAL CONDUCTOR WAS STRETCHED, THERE WAS BLOOD/BODY FLUIDS ON ALL CONDUCTORS (NOT OBSTRUCTED), AND BLOOD IN/ON HELIX MECHANISM. THE OUTER INSULATION WAS BREACHED (CLAVICLE-RIB CRUSH), THE INNER INSULATION WAS TORN, AND THERE WAS A FLEXED, CLAVICLE-RIB. THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD LOW PACING IMPEDANCES, OVERSENSING AND HIGH/UNSTABLE/UNMEASURABLE THRESHOLDS. ALSO REPORTED WAS AN APPARENT CONDUCTOR FRACTURE. THE LEAD WAS REMOVED AND RETURNED, A NEW LEAD WAS IMPLANTED. THERE WAS NO FURTHER 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 75 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR