BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1717992 · Received June 10, 2010

    Report

    Report Number
    2649622-2010-06169
    Event Type
    Injury
    Date Received
    June 10, 2010
    Date of Event
    April 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. ANALYSIS OF THE DEVICES ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE MAX RV PACE IMPEDANCE MEASUREMENT HAS PERIODS OF VARIABILITY AND WAS HIGHEST AT THE LAST READING. THE RANGE WAS 408 - 2400 OHMS. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 665 AND ALL COUNTS OCCURRED SINCE (B)(6) 2010. UPON ANALYSIS, NO ANOMALIES FOUND, HOWEVER DEFIB CONDUCTOR WAS DISTORTED, OUTER TUBING OVERLAY BREACHED CUT, WHITE SUBSTANCE ON EXPOSED DEFIB COIL, APPARENT EXPLANT DAMAGE, AND BLOOD ON OUTER TUBING OVERLAY AND HELIX; THE ANALYST NOTED THAT THERE WAS ONLY ONE SET OF SETSCREW MARKS ON THE IS-1 PIN AND IT IS TOO PROXIMAL, THUS LEAD WAS NOT FULLY INSERTED INTO THE DEVICE; FULL LEAD RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, HOWEVER DISTAL AND PROXIMAL CONDUCTORS WERE DISTORTED, OUTER INSULATION BREACHED CUT, DISTAL CONDUCTOR FRACTURE (OVERSTRESS), HELIX DISTORTED/BENT, APPARENT EXPLANT DAMAGE, AND BLOOD ON PROXIMAL CONDUCTOR AND HELIX; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE REPORT TO TECHNICAL SERVICES NOTED DURING DEVICE INTERROGATION IMPEDANCE WAS HIGH SEVERAL DAYS DURING THE PAST WEEK AND OVERSENSING WAS OCCURRING WITH THE RIGHT VENTRICULAR LEAD. CONSEQUENTLY, A REVISION PROCEDURE WAS COMPLETED: RIGHT VENTRICULAR LEAD EXCISED AND REPLACED. HOWEVER, DURING THE EXTRACTION OF THE RIGHT VENTRICULAR LEAD, THE ATRIAL LEAD DISLODGED. PARTIAL ATRIAL LEAD EXCISED, AND IT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THESE EVENTS.

    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 51 YR Required Intervention D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB