BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

    MDR report key: 7563113 · Received June 1, 2018

    Report

    Report Number
    2182208-2018-01024
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    January 1, 2018
    Report Date
    June 6, 2018
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE/RACE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/56 YEARS OLD/WHITE.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 REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿PROSPECTIVE RANDOMIZED EVALUATION OF IMPLANTABLE CARDIOVERTER- DEFIBRILLATOR PROGRAMMING IN PATIENTS WITH A LEFT VENTRICULAR ASSIST DEVICE.¿ RICHARDSON T.D., HALE L., ARTEAGA C., XU M., KEEBLER M., SCHLENDORF K., DANTER M., SHAH A., LINDENFELD J., ELLIS C.R. JOURNAL OF THE AMERICAN HEART ASSOCIATION. 2018; 7(5). J AM HEART ASSOC. 2018;7:E007748. DOI: 10.1161/JAHA.117.007748. THIS IS A CLINICAL TRIAL. URL: HTTPS://WWW.CLINICALTRIALS.GOV. UNIQUE IDENTIFIER: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE AUTHOR WHO INDICATED THAT THERE WAS NO ADDITIONAL INFORMATION AVAILABLE, BUT THAT THE STUDY AUTHORS INDICATED THAT THE PROGRAMMING FEATURES OF THIS MANUFACTURER WOULD "BE BEST SUITED" FOR CERTAIN PATIENTS WITH A LEFT-VENTRICULAR-ASSIST-DEVICE, AS COMPARED TO OTHER MANUFACTURERS.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). THE ARTICLE REPORTED THERE WERE PATIENTS WHO EXPERIENCED INAPPROPRIATE SHOCKS; EXTRA HOSPITALIZATION WAS ALSO OBSERVED. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. THE STATUS/LOCATION OF THE DEVICE 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
    405449 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, PLC MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R