BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1925777 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14052
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 5, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD INCREASING THRESHOLDS. SINCE THE PATIENT WAS PACEMAKER DEPENDENT, AND THEIR VENOUS SYSTEM WAS OCCLUDED ON THE RIGHT SIDE, A NEW SYSTEM WAS IMPLANTED ON THEIR LEFT SIDE. THE OLD SYSTEM WAS REPROGRAMMED TO VVI 30 BPM, UNIPOLAR SENSING, AS A BACKUP SYSTEM. IT WAS NOTED THAT THE BIPOLAR SENSING WAS POOR. ABOUT ONE MONTH LATER, THE CHRONIC DEVICE WAS REMOVED, AND THE RIGHT ATRIAL AND RIGHT VENTRICULAR CHRONIC LEADS WERE CAPPED WHEN IT WAS NOTED THAT THE ATRIAL CHRONIC LEAD WAS DISCOLORED, AND BLOOD WAS IN THE LUMIN OF BOTH THE ATRIAL AND VENTRICULAR CHRONIC LEADS. NO PATIENT COMPLICATIONS WERE 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. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R