BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 7477457 · Received May 1, 2018

    Report

    Report Number
    2182208-2018-00816
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    September 18, 2017
    Report Date
    May 1, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    1 CARD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. MULTIPLE PATIENTS AND MANUFACTURERS WERE REFERENCED IN THE ARTICLE, BUT WITH NO MANUFACTURER DEVICE/PRODUCT FAILURE CORRELATION/SERIAL NUMBERS. THE GENDER OF THE BASELINE CHARACTERISTICS IS FEMALE AND THE BASELINE AGE IS APPROXIMATELY 69 YEARS OLD. POSSIBLE MODELS INCLUDE ADAPTA ADDR AND ENPULSE DR. 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. 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: ACCURACY OF THE PACEMAKER EVENT RECORDER VERSUS HOLTER-ECG TO DETECT BOTH SYMPTOMATIC AND ASYMPTOMATIC VENTRICULAR ARRHYTHMIAS. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2018; 29(1):154-159. DOI: 10.1111/JCE.13370. 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 PULSE GENERATORS (IPGS). MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE STUDY COMPARED THE ACCURACY OF THE IPG EVENT RECORDER VERSUS A HOLTER- ELECTROCARDIOGRAM (ECG) TO DETECT SYMPTOMATIC AND ASYMPTOMATIC VENTRICULAR ARRHYTHMIAS. THE ARTICLE REPORTS THAT VENTRICULAR ARRHYTHMIAS ARE UNDERESTIMATED BY IPG EVENT RECORDINGS. THE STATUS OF THE DEVICES IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319361 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR