BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 6936342 · Received October 10, 2017

    Report

    Report Number
    2182208-2017-01794
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    January 1, 2012
    Report Date
    July 31, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND THE SUBSEQUENT FOLLOW UP INFORMATION OBTAINED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 72 YEARS OLD. 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. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE DEVICE REFERENCED. POSSIBLE MODELS COULD INCLUDE: CONCERTO, CONCERTO II, CONSULTA, PROTECTA, PROTECTA XT, AND SYNCRA: ALL TM. REFERENCED ARTICLE: ¿REASONS FOR LOSS OF CARDIAC RESYNCHRONIZATION THERAPY PACING. INSIGHTS FROM 32,844 PATIENTS.¿ CIRC ARRHYTHM ELECTROPHYSIOL. 2012;5:884-888. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENTS WITH LOSS OF PACING, INAPPROPRIATE PROGRAMMED SENSED AND PACED INTERVALS, AND A LOSS OF CAPTURE; ALL WITH UNKNOWN TREATMENT/RESOLUTION. THE STATUS/LOCATION OF THE DEVICE IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715719 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R