BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2200560 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11010
    Event Type
    Injury
    Date Received
    August 11, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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): PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED, AND REVEALED THAT ON (B)(6) 2010 A PATIENT ALERT OCCURED DUE TO HVB-HVA LEAD IMPEDANCE BEING GREATER THAN 200 OHMS. THE WEEKLY LOG DATA ALSO SHOWED VARYING IMPEDANCE FOR MAX HVB OVER THE RANGE OF 78 TO 240 OHMS BETWEEN (B)(6) 2009 AND (B)(6) 2010. UPON ANALYSIS, NO ANOMALIES FOUND, HOWEVER, THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE DEFIBRILLATION CONDUCTOR FRACTURED DUE TO OVERSTRESS, THE OUTER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED; PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, HOWEVER THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS MELTED, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE; PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, HOWEVER 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 APPARENT EXPLANT DAMAGE; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH AND VARYING IMPEDANCE ON THE RIGHT VENTRICULAR LEAD. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. DURING THE RIGHT VENTRICULAR LEAD EXTRACTION, THE RIGHT ATRIAL LEAD AND LEFT VENTRICULAR LEAD BOTH BECAME DISLODGED. BOTH OF THESE LEADS WERE ALSO EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 62 YR Hospitalization| R 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIBRILLATOR