BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1842690 · Received September 23, 2010

    Report

    Report Number
    2649622-2010-09043
    Event Type
    Injury
    Date Received
    September 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTED ADVERSE EVENT. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT IS OBSERVED ON (B)(6) 2010 FOR ATRIAL IMPEDANCE HIGHER THAN 3000 OHMS. THIS IS ALSO EASILY OBSERVED IN THE WEEKLY PACE LEAD IMPEDANCE TREND CHARTS BEGINNING THE WEEK OF (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD AN APPARENT FRACTURE. THE IMPEDANCE WAS GREATER THAN 3000 OHMS AND FLUCTUATED BETWEEN 3000 AND 600 OHMS. THE PATIENT WAS SCHEDULED FOR A DEVICE AND LEAD REPLACEMENT AND DURING THE PROCEDURE, THE ATRIAL LEAD WAS TESTED UNIPOLAR AND HAD A THRESHOLD OF 2.0V AT 0.5 MS AND IMPEDANCE MEASURED 516 OHMS. THE LEAD WAS TESTED BIPOLAR AND IT HAD HIGH IMPEDANCE AND NO CAPTURE. THE DEVICE WAS REPLACED AND THE EXISTING ATRIAL LEAD WAS HOOKED UP TO THE NEW DEVICE WITH THE DEVICE PACING AND SENSING UNIPOLAR. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB