BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 7566899 · Received June 4, 2018

    Report

    Report Number
    2182208-2018-01036
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    April 17, 2018
    Report Date
    July 20, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: RADIOTHERAPY IN PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES: CLINICAL AND DOSIMETRIC ASPECTS. MEDICAL ONCOLOGY. 2018; 35(5). DOI: 10.1007/S12032-018-1126-3. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED INDICATED THE PATIENT PASSED AWAY FROM CANCER. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE DEVICE DURING THE STUDY.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). THE ARTICLE REPORTS THAT THE PATIENT EXPERIENCED ALTERED SENSING AFTER ELEVEN MONTHS FROM THE END OF RECEIVING RADIOTHERAPY FOR LUNG CANCER. THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410083 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R