BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 5712187 · Received June 9, 2016

    Report

    Report Number
    2182208-2016-01502
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    January 1, 2016
    Report Date
    March 3, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    1-CARD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND THE SUBSEQUENT FOLLOW UP INFORMATION OBTAINED FROM THE AUTHOR/PHYSICIAN. THIS EVENT OCCURRED OUTSIDE THE US. MULTIPLE PATIENTS AND MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE OF THE PATIENTS IS MALE/70 YEARS OF AGE. 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 PMA NUMBER FOR THIS REPORT LISTED IS PART OF A COMBINATION OF PMAS CONSIDERED THE "1-CARD" AND CONSISTS OF P820003, P850051, P890003, P930022, P970012 AND P980035. REFERENCED ARTICLE: A PROSPECTIVE COMPARISON OF REMOTE MONITORING SYSTEMS IN IMPLANTABLE CARDIAC DEFIBRILLATORS: POTENTIAL EFFECTS OF FREQUENCY OF TRANSMISSIONS. J. INTERVENT. CARD. ELECTROPHYSIOL. 2016;45(1):81-90.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS. MULTIPLE PATIENTS AND 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 "FALSE POSITIVE" DEVICE ALERTS, INCORRECTLY-DETECTED ATRIAL OVERSENSING (SEEN AS ATRIAL FIBRILLATION (AF), INAPPROPRIATE DEVICE THERAPIES DELIVERED AND NON-SPECIFIC "OTHER" ALLEGATIONS. THERE WERE DEVICE REPROGRAMMING AND SURGICAL IMPLANT REVISIONS DONE. THE STATUS OF ALL DEVICES IS UNKNOWN. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE AUTHOR/PHYSICIAN WHO INDICATED THAT THERE WERE NO "PARTICULAR PROBLEM OR ISSUE" WITH THE DEVICES "WITH THE EXCEPTION OF THE EXPERIENCE REPORTED IN THE ARTICLE." NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367479 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R