BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811160 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15836
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 FOR: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND THE CONNECTOR PIN/CRIMP CORE CORRODED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS TISSUE ON THE HELIX. THE ANALYST VISUAL COMMENT REVEALED THAT THERE IS CORROSION ON THE CONNECTOR PIN WHERE THE SET-SCREW WAS PLACED WHICH CAUSED THE HIGH IMPEDANCE READINGS. EVALUATION SUMMARY FOR: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND THE CONNECTOR PIN/CRIMP CORE CORRODED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE ANALYST VISUAL COMMENT REVEALED THAT THERE IS SEVERE CORROSION OF THE CONNECTOR PIN FOR 360 DEGREES CIRCUMFERENCE WHICH CAUSED THE HIGH IMPEDANCE READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE RIGHT VENTRICULAR LEAD (RV) AND THE RIGHT ATRIAL LEAD (RA) SHOWED IMPEDANCES OVER 7558 OHMS. IT WAS CONFIRMED THAT THE LEADS DID NOT GO THROUGH HIGH IMPEDANCE AT THE SAME TIME. IT WAS ALSO REPORTED THAT LEAD WARNINGS TRIGGERED ON BOTH LEADS AS WELL AS INCREASING THRESHOLDS. THE RV AND RA LEADS WERE REMOVED AND REPLACED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR