BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3965185 · Received July 29, 2014

    Report

    Report Number
    2182208-2014-01874
    Event Type
    Death
    Date Received
    July 29, 2014
    Date of Event
    June 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    2014 (B)(4), RN, BSN, MSN: THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. A FOLLOW UP LETTER WAS SENT TO THE AUTHOR OF THE ARTICLE WITH NO RESPONSE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCED ARTICLE: OUTCOMES IN PACEMAKER-DEPENDENT PATIENTS UPGRADED FROM CONVENTIONAL PACEMAKERS TO CARDIAC RESYNCHRONIZATION THERAPY- DEFIBRILLATORS. HEART RHYTHM. 2014;11(6):1008-1014. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD AND DEVICE MODEL. MULTIPLE PATIENTS AND WITH MULTIPLE ADVERSE EVENTS INCLUDING DEATHS AND MULTIPLE FAILURE MODES WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED A REPORT OF ADVERSE EVENTS SUCH AS 24 PATIENT DEATHS, HEMATOMAS, AND INAPPROPRIATE SHOCKS AND INFECTION. THE FOLLOWING FAILURE MODES WERE ALSO REPORTED: LEAD DISLODGMENT, HIGH PACING THRESHOLDS, OVERSENSING, FAILURE TO PACE, LEAD FRACTURE, LEAD NOT SEATED CORRECTLY IN THE DEVICE HEADER .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441452 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE LWS MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Death MDT-TACHY-LEAD IMPLANT UNK