BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2810661 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16028
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 17, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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: (B)(4) - THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) - THE FULL LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, WHICH WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. THE OUTER INSULATION HAD COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD. THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) - THE FULL LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED) AND WERE MELTED. THE OUTER INSULATION WAS MELTED AND HAD COSMETIC DEPRESSION. THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) - THE FULL LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE OUTER INSULATION HAD A BREACHED CUT AND COSMETIC DEPRESSION; THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SEPSIS. THE DEVICE AND LEADS WERE REMOVED. IT WAS NOTED THAT THERE WERE NO DEVICE SYSTEM PERFORMANCE ISSUES. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R