BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2790317 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14125
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. EVALUATION SUMMARY: (B)(4). THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND, NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND, NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS OF THE DATA REVEALED THERE WAS A RESISTANCE/IMPEDANCE INCREASE. THE S2D DATA FILE (B)(4) SHOWS ATRIAL LEAD IMPEDANCE INCREASE FROM 756 TO OPEN MAX OHMS BETWEEN (B)(4) 2012. THE ATRIAL IMPEDANCE AT IMPLANT EQUALED 616 OHMS. AND THE ATRIAL LIFETIME IMPEDANCE MAX/MIN EQUALED OPEN/662 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD INCREASED THRESHOLD, NON-CAPTURE AND INCREASED IMPEDANCE. IT WAS ALSO REPORTED THAT THE LEAD WAS FRACTURED. THE LEAD WAS PARTIALLY EXPLANTED, CAPPED, AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| SEDR01 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| SEDR01 IMPLANTABLE PACEMAKER/CARDIO/DEFIB