BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1912202 · Received December 2, 2010

    Report

    Report Number
    2649622-2010-12190
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    October 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR DISTORTED AND STRETCHED, BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING OVERLAY MELTED AND BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM, LEAD STRETCHED, APPARENT EXPLANT DAMAGE. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR STRETCHED AND BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER INSULATION MELTED, OUTER TUBING OVERLAY BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED. (B)(4) DISTAL AND PROXIMAL CONDUCTOR FRACTURED, ALL CONDUCTORS DISTORTED AND BLOOD/BODY FLUID (NOT OBSTRUCTED), ALL INSULATORS BREACHED (CLAVICLE-RIB CRUSH), OUTER INSULATION COSMETIC ESC AND DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SYSTEM WAS EXPLANTED ON (B)(6) 2010 DUE TO "PACEMAKER INFECTION, SWELLING." FOLLOW UP LATER REVEALED THE PATIENT DIED 9 DAYS LATER. THE INFECTION WAS BELIEVED TO HAVE STARTED WITH AN ABSCESS IN THE PATIENT MOUTH. AFTER THE EXPLANT, THE PHYSICIAN WANTED TO WAIT FOR THE PATIENT TO IMPROVE BEFORE REIMPLANTING, BUT THE PATIENT "PASSED AWAY DUE TO COMPLICATIONS FROM THE INFECTION." THE PATIENT HAD NOT BEEN PACEMAKER DEPENDENT AND PRIOR TO THE INFECTION, HAD NO COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H| L| R