BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2812922 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16957
    Event Type
    Injury
    Date Received
    October 31, 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
    NM, US
    Reporter Occupation
    OTHER

    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 BY THE PATIENT THAT THE PATIENT'S LEAD "BROKE" AND HAD TO BE REPLACED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE PHYSICIAN THAT THE RIGHT VENTRICULAR (RV) LEAD HAD "LOW RESISTANCE AND LACK OF CONTINUITY AND WAS DEFECTIVE." IT WAS ALSO NOTED THAT THE ATRIAL LEAD HAD BECOME "DETACHED" AND "OUT OF POSITION". THE RV LEAD WAS EXPLANTED AND REPLACED AND THE ATRIAL LEAD WAS REPOSITIONED AND REMAINS IN USE. 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 65 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR