BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE

    MDR report key: 2790280 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03257
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME TO A DEVICE MARKETED IN THE U.S. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH THRESHOLDS AND UNDERSENSING OBSERVED IN THE RIGHT VENTRICULAR PACING LEAD. THE LEAD WAS CAPPED AND WAS REPLACED. THE PATIENT IS A PARTICIPANT IN THE PANORAMA CLINICAL STUDY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALLINE IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. ICL08JB

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R IMD49 IMPLANTABLE PACING LEAD| T70A1 IMPLANTABLE PULSE GENERATOR