BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1864926 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10890
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THAT DURING THE LAST 6 MONTHS THE IMPEDANCE HAS SLOWLY BEEN GOING DOWN. ON ONE PARTICULAR DAY THE IMPEDANCE VARIED SIGNIFICANTLY. IT WAS ALSO REPORTED DURING THIS TIME THAT THE THRESHOLD HAS ALSO RISEN SLIGHTLY AND WAS CONSIDERED HIGH. THE PATIENT IS PACER DEPENDANT AND THEY PLAN TO MONITOR THE PATIENT. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LAST 6 MONTHS THE IMPEDANCE HAS SLOWLY BEEN GOING DOWN. ON ONE PARTICULAR DAY THE IMPEDANCE VARIED SIGNIFICANTLY. IT WAS ALSO REPORTED DURING THIS TIME THAT THE THRESHOLD HAS ALSO RISEN SLIGHTLY AND WAS CONSIDERED HIGH. THE PATIENT IS PACER DEPENDANT AND THEY PLAN TO MONITOR THE PATIENT. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICLE (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH THRESHOLDS. 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. 5068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O| R 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR