BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1796681 · Received August 12, 2010

    Report

    Report Number
    2649622-2010-07961
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    June 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED HIGH RESISTANCE/IMPEDANCE. THE MAX SVC IMPEDANCE MEASUREMENT HAS HAD PERIODS OF ELEVATED IMPEDANCE MEASUREMENT, WITH PEAK VALUES FROM 122 - 164 OHMS AND A SINGLE READING OF 888 OHMS ON (B)(6) 2010. THE DISTAL SEGMENT OF THE LEAD WAS LATER RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEFIB CONDUCTOR WAS DISTORTED, THE OUTER TUBING OVERLAY WAS MELTED, THE HELIX/LOBE WAS DISTORTED/BENT AND THAT BLOOD/BODY FLUID WAS ON THE OUTER TUBING OVERLAY AND IN/ON THE HELIX/LOBE MECHANISM. (B)(4) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER. NO ANOMALIES WERE FOUND DURING ANALYSIS. IT WAS NOTED THAT THE OUTER INSULATION WAS BREACHED CUT AND BLOOD/BODY FLUID WAS LOCATED ON THE PROXIMAL CONDUCTOR.

    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) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED HIGH RESISTANCE/IMPEDANCE. THE MAX SVC IMPEDANCE MEASUREMENT HAS HAD PERIODS OF ELEVATED IMPEDANCE MEASUREMENT, WITH PEAK VALUES FROM 122 - 164 OHMS AND A SINGLE READING OF 888 OHMS ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEEPING AND THAT THE LEAD IMPEDANCE WAS GREATER THAN 200 OHMS. THE CLINICIAN STATED THAT THE LEAD IMPEDANCE TREND HAD BEEN FLUCTUATING. THE LEAD WAS REMOVED AND REPLACED. DURING THE LEAD REMOVAL, THE ATRIAL LEAD BECAME DISLODGED AND WAS REPLACED. NO FURTHER 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 21 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB