BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 3991741 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02096
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. AUTO LEAD DIAGNOSTICS SHOWS ATRIAL SHORT CIRCUIT PACES WITH LEAD IMPEDANCE LESS THAN 200 OHMS. AN ATRIAL LEAD WARNING OCCURRED ON (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PECTORAL POCKET STIMULATION. IT WAS ALSO REPORTED THAT THE UNIPOLAR RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAD LOW IMPEDANCE, AND THE RA LEAD WAS UNDERSENSING P WAVES. THE LEADS ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468519 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4511

    Patients

    Seq Age Sex Outcome Treatment
    1 4011 LEAD