BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2124008 · Received June 14, 2011

    Report

    Report Number
    2182208-2011-00717
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    February 24, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. RV PACE LEAD IMPEDANCE RECORDS A PATIENT ALERT ON (B)(6) 2011 AT GREATER THAN 2000 OHMS. THIS BEHAVIOR MAY BE OBSERVED ON THE PACING WEEKLY MEASUREMENT LONG AS A RISE FROM 378 OHMS THE WEEK OF (B)(6) 2011 TO A VALUE OF 1864 OHMS THE WEEK OF (B)(6) 2011 THEN ABOVE 2000 OHMS ON THE (B)(6) 2011. MULTIPLE SHORT V-V SENSED EVENTS OF LESS THAN 220 MS ARE OBSERVED BETWEEN THE (B)(6) 2011. (47 EPISODES NST, 3 EPISODES VF). HIGH V-SIC COUNTS ARE OBSERVED WITH 1869 COUNTS OCCURRING SINCE THE (B)(6) 2011. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING AND HIGH IMPEDANCE. THE PATIENT RECEIVED INAPPROPRIATE THERAPY. THE STATUS OF THE LEAD IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB