BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3936226 · Received July 15, 2014

    Report

    Report Number
    2182208-2014-01847
    Event Type
    Death
    Date Received
    July 15, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER-DEATH OR DEVICE-FAILURE CORRELATION. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO INDICATION OF ANY SPECIFICS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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: FEASIBILITY, SAFETY, AND SHORT-TERM OUTCOME OF LEADLESS ULTRASOUND-BASED ENDOCARDIAL LEFT VENTRICULAR RESYNCHRONIZATION IN HEART FAILURE PATIENTS: RESULTS OF THE WIRELESS STIMULATION ENDOCARDIALLY FOR CRT (WISE-CRT) STUDY. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIODEFIBRILLATORS (ICDS). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. MULTIPLE FAILURE MODES AND SERIOUS ADVERSE EVENTS (SAES) WERE REFERENCED IN THE ARTICLE, WITH NO SPECIFIC DEVICE MODEL FAILURE/SAE INDICATIONS. THE FAILURE AND/OR SAE MODES WERE NOTED AS: DEATH, LOSS OF LEFT VENTRICULAR (LV) LEAD PACING CAPTURE, EARLY BATTERY DEPLETION, PERIPHERAL NEUROSTIMULATION (PNS), PERICARDIAL EFFUSION, AND DEVICE INACTIVATION. THE STATUS OF THE ICD IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412246 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

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