BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 5439652 · Received February 16, 2016

    Report

    Report Number
    2182208-2016-00699
    Event Type
    Injury
    Date Received
    February 16, 2016
    Date of Event
    January 1, 2016
    Report Date
    February 4, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P820003
    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. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/(B)(6). 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. 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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: RESULTS OF REMOTE FOLLOW-UP AND MONITORING IN YOUNG PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES. CARDIOL. YOUNG. 2014;26(1):53-60. CONCOMITANT PRODUCT: CARELINK REMOTE MONITOR. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING CARDIAC IMPLANTABLE ELECTRONIC DEVICES AND REMOTE MONITORING. MULTIPLE PATIENTS 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 LEAD FRACTURES, ELECTROMAGNETIC INTERFERENCE (EMI), CAPTURE MANAGEMENT ISSUES, LEAD DISLODGEMENTS, IMPEDANCE WARNINGS, DEVICE THORACIC THRESHOLDS ALERT ISSUES, AND DEVICE INAPPROPRIATE DETECTIONS. THE REMOTE MONITORS HAD MISSED TRANSMISSIONS, SEND PHASE ISSUES, AND PATIENT NON-COMPLIANCE AND PATIENT MONITOR USAGE ISSUES. THERE WERE LEAD REVISIONS DONE FOR SOME OF THE LEADS AND DEVICE REPROGRAMMING WAS ALSO DONE. THE STATUS OF THE DEVICES, LEADS AND MONITORS IS UNKNOWN. 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
    96154 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Required Intervention