BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3053151 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05451
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER COMMUNICATION HAS BEEN RECEIVED REGARDING THIS ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION WHEN THIS PHYSICIAN CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REQUESTING REVIEW OF A 12 LEAD EKG RHYTHM STRIP. THE VISUAL QUALITY OF THE EKG STRIP WAS POOR, HOWEVER THERE APPEARED TO BE ISSUES WITH NON-CAPTURE/NON-SENSING AT A RATE AROUND 90PPM/680MS. WHEN THE PATIENT WAS CHECKED LATER THAT NIGHT, THE DEVICE FUNCTION APPEARED NORMAL. THEN OVERNIGHT, THE SAME LOSS OF CAPTURE WAS OBSERVED AGAIN. THE PHYSICIAN WAS ON HIS WAY TO EVALUATE THE PATIENT AND STATED HE WOULD CONTACT TS AGAIN WITH FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154261 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 1290| 1283| 4086| 4034