BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203343 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11687
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    February 8, 2011
    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
    NJ, 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. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS REPORTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS TORN, THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS REPORTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A WHITE SUBSTANCE, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED, HAD IMPROPER SENSING AND IMMEASURABLE THRESHOLDS. THE DEVICE WAS REPROGRAMMED AFTER THE DISLODGEMENT FROM A DDD MODE TO AN AAI MODE. THE LEAD WAS REPOSITIONED AND THE DEVICE WAS PROGRAMMED BACK TO DDD MODE. IT WAS FURTHER REPORTED THAT THREE WEEKS AFTER THE REPOSITIONING THE PHYSICIAN DECIDED TO REPLACE THE LEAD DUE TO HIGH THRESHOLDS. DURING THE REPLACEMENT PROCEDURE THE PHYSICIAN NOTED THAT THE RV LEAD MAY NOT HAVE BEEN SUTURED DOWN PROPERLY DUE TO HOW EASILY IT WAS TO REMOVE. AFTER REMOVAL OF THE RV LEAD THE PHYSICIAN WAS UNABLE TO GAIN ACCESS TO THE HEART DUE TO AN OCCLUDED VEIN ON THE RIGHT SIDE. THE LEFT SIDE WAS NOT AN OPTION AS THE PATIENT HAD A SHUNT ON THE LEFT SIDE FOR DIALYSIS. THE DEVICE, RIGHT ATRIAL LEAD AND RV LEAD WERE ALL EXPLANTED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R