BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3717375 · Received April 1, 2014

    Report

    Report Number
    2182208-2014-00606
    Event Type
    Death
    Date Received
    April 1, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DATE OF DEATH IS NOT KNOWN AND IS AN ESTIMATE BASED ON THE PUBLICATION DATE. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: SHORT- AND LONG-TERM ELECTRICAL PERFORMANCE OF THE 5086MRI PACING LEAD. HEART RHYTHM,. 2014;11(2):222-229. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THESE LEAD MODELS. MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES AND ADVERSE EVENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING ADVERSE EVENTS AND FAILURE MODES: DEATHS, PNEUMOTHORAX, CARDIAC PERFORATION, CHEST PAIN, SITE INFECTION, PNEUMONIA, SYNCOPE, DEVICE SITE STIMULATION, EXTREMITY PAIN, PULMONARY EDEMA, PYREXIA, SUBCLAVIAN VEIN THROMBOSIS, TRANSIENT ISCHEMIC ATTACK, HEART FAILURE DECOMPENSATION, PREMATURE ATRIAL CONTRACTIONS, PACEMAKER SYNDROME, PAROXYSMAL NOCTURNAL DYSPNEA, RESPIRATORY ACIDOSIS, RESPIRATORY DISTRESS, SHOULDER PAIN, STROKE, LEAD DISLODGMENT, ELEVATED PACING THRESHOLDS, FAILURE TO CAPTURE, AND CONNECTION ISSUES. THE STATUS OF THE LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194526 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death