BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1863156 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10569
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    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 THERE WAS A RIGHT VENTRICULAR NON-DEFIB LEAD PROBLEM AND IT WAS NOTED THAT THE LEAD FAILED. THE LEAD COULD NOT BE EXTRACTED AND ANOTHER LEAD COULD NOT BE PUT IN DUE TO PATIENT'S ANATOMY. DECISION WAS MADE TO RECONNECT THE PACED SENSED PORTION OF THE ALREADY IMPLANTED RIGHT VENTRICULAR DEFIB LEAD. THE NON-DEFIB LEAD WAS CAPPED. THE PATIENT ALSO REPORTED THAT THE RIGHT VENTRICULAR DEFIB LEAD WAS "FAULTY" AND "DEFECTIVE". THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT VENTRICULAR NON-DEFIB LEAD PROBLEM AND IT WAS NOTED THAT THE LEAD FAILED. THE LEAD COULD NOT BE EXTRACTED AND ANOTHER LEAD COULD NOT BE PUT IN DUE TO PATIENT'S ANATOMY. DECISION WAS MADE TO RECONNECT THE PACED SENSED PORTION OF THE ALREADY IMPLANTED RIGHT VENTRICULAR DEFIB LEAD. THE NON-DEFIB LEAD WAS CAPPED. 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 NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD