BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 4731705 · Received April 27, 2015

    Report

    Report Number
    2182208-2015-01420
    Event Type
    Death
    Date Received
    April 27, 2015
    Date of Event
    January 1, 2015
    Report Date
    April 8, 2015
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DXY
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEVICE/PRODUCT FAILURE CORRELATION. THE BASELINE AGE/GENDER IS (B)(6) AND MALE. THE DATE OF DEATH IS PURELY AN ESTIMATE, AS THERE IS NO DIRECT CORRELATION WITH DEVICE SERIAL NUMBERS. 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: EPICARDIAL LEADS IN ADULT CARDIAC RESYNCHRONIZATION THERAPY RECIPIENTS: A STUDY ON LEAD PERFORMANCE, DURABILITY, AND SAFETY. HEART RHYTHM. 2015;12(3):533-539. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (CRT-DS) AND I IMPLANTABLE LEADS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT THERE WERE PATIENT DEATHS, AS WELL AS COMPLICATIONS SUCH AS INFECTION, SKIN EROSIONS, PACING THRESHOLD INCREASE/LOSS OF CAPTURE, PHRENIC NERVE STIMULATION/INJURY, LEAD REVISIONS, AND ¿MYOCARDIAL INFARCTION THAT MIGHT HAVE BEEN RELATED TO EPICARDIAL LEAD PLACEMENT.¿ MEDICAL AND/OR SURGICAL INTERVENTION WAS COMPLETED ON SOME, IF NOT ALL PATIENTS. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. THE CAUSE OF DEATH AND DEVICE MANUFACTURER/RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276825 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, PLC MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death| R 4968 IMPLANTABLE PACING LEAD