BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 6200635 · Received December 22, 2016

    Report

    Report Number
    2182208-2016-02932
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    June 19, 2016
    Report Date
    December 6, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    1-CARD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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. THE EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. 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. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 9 YEARS OLD. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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. REFERENCED ARTICLE: DALILI M, ABBASZADEH R, KHORGAMI M-R, HOSSEINI S. EFFICACY OF RATE MODULATORS IN CHILDREN WITH SINGLE-CHAMBER PACEMAKERS. RES CARDIOVASC MED. 2016;5(4):2251-9572.

    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 WHICH CONTAINED INFORMATION REGARDING THE EXERCISE PERFORMANCE OF PEDIATRIC PATIENTS WITH AND WITHOUT 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 ARTICLE NOTED BETTER EXERCISE PERFORMANCE IN PEDIATRIC PATIENTS WITHOUT IPGS AND CONCLUDED THAT PACEMAKER ACCELEROMETERS FAILED TO MEET PHYSIOLOGICAL DEMANDS. THERE WERE NO ADVERSE EVENTS NOTED AND NO INDICATION OF PROGRAMMING CHANGES NEEDED. THERE WAS NO MENTION OF EXPLANTS SO THE IPGS REMAIN IN USE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THE EXERCISE PERFORMANCE OF PEDIATRIC PATIENTS WITH AND WITHOUT 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 ARTICLE NOTED BETTER EXERCISE PERFORMANCE IN PEDIATRIC PATIENTS WITHOUT IPGS. THERE WERE NO ADVERSE EVENTS NOTED AND NO INDICATION OF PROGRAMMING CHANGES NEEDED. THERE WAS NO MENTION OF EXPLANTS SO THE IPGS REMAIN IN USE. 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
    850312 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR EPICARDIAL PACING LEAD, ENDOCARDIAL PACING LEAD