BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 8380150 · Received February 28, 2019

    Report

    Report Number
    2182208-2019-00393
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    January 1, 2018
    Report Date
    February 28, 2019
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DXY
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS AND MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS/MANUFACTURERS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS (B)(6) 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. NO FURTHER INFORMATION IS AVAILABLE. REFERENCED ARTICLE: ¿EXTERNAL ELECTRICAL CARDIOVERSION IN PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES: IS IT SAFE AND IS IMMEDIATE DEVICE INTERROGATION NECESSARY?¿ PACE - PACING AND CLINICAL ELECTROPHYSIOLOGY. 2018; 41(10):1336-1340. DOI:10.1111/PACE.13467. 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 EXTERNAL ELECTRICAL CARDIOVERSION IN PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WAS A ¿SMALL, BUT SIGNIFICANT¿ DECREASE IN RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) IMPEDANCES ¿IMMEDIATELY¿ AFTER THE ELECTRICAL CONVERSIONS. THE AUTHOR NOTES THAT AT FOLLOW UP THE RA IMPEDANCE RECOVERED, BUT THE RV IMPEDANCE DID NOT RETURN TO THE VALUE BEFORE THE ECV. OF NOTE, THERE WERE NO COMPLICATIONS OR ADVERSE EVENTS AFTER THE EXTERNAL ECVS, PER THE AUTHOR. THE STATUS/LOCATION OF THE DEVICE IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171286 UNKNOWN PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, PLC MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR