BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC III MARQUIS

    MDR report key: 2810451 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03699
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    June 1, 2012
    Report Date
    September 14, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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: UNMASKING OF MYOPOTENTIAL OVERSENSING BY AN INTEGRATED BIPOLAR DEFIBRILLATOR LEAD FOLLOWING AV NODE ABLATION. HERZSCHRITTMACHERTHER. ELEKTROPHYSIOL. (B)(6) 2012; 23(2):131-134. THE PATIENT HAD A REVISION OF THE SYSTEM. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND AN ADDITIONAL PACE/SENSE LEAD WAS IMPLANTED. AFTER SURGERY, THE PATIENT'S SYMPTOMS WERE RESOLVED AND NO FURTHER OVERSENSING WAS RECORDED. FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS DEVICE. IT WAS REPORTED THAT THE PATIENT RECEIVED AN ABLATION PROCEDURE FOR THE SLOW VENTRICULAR TACHYCARDIA (VT) AND THE AV NODE. AFTER THE PROCEDURE, THE PATIENT STARTED TO COMPLAIN ABOUT DIZZINESS. REVIEW OF THE DEVICE NOTED THAT THERE WERE "SIGNIFICANT PAUSES DUE TO INHIBITION FO PACING." THE ARTICLE REPORTS THAT THE DEVICE WAS REPROGRAMMED. A CHEST X-RAY SHOWED STABLE LEAD POSITIONS. DURING REPEAT INTERROGATIONS OF THE DEVICE, "PROVOCATIVE MANEUVERS" WERE DONE AND THERE WAS NO EFFECT ON DEVICE FUNCTION; HOWEVER, DURING ISOMETRIC EXERCISES, PACING INHIBITION AND DIZZINESS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III MARQUIS IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC, INC. 7279

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R