BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2790548 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14428
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LEAD WARNINGS FOR THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE RA AND RV LEADS HAD IMPEDANCE LESS THAN 200 OHMS, HIGH THRESHOLDS AND NO UNIPOLAR SENSING. THE RA AND RV LEADS WERE 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. 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR