BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1072556 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03975
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    January 31, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 - INNER TUBING KINKED/BUCKLED. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL ANALYST COMMENT - THE HELIX WILL NOT RETRACT. THIS IS MOST LIKELY DUE TO THE BUCKLED INNER TUBING AND SLIGHTLY BENT HELIX. MOST LIKELY HAPPENED DURING THE REPOSITIONING ATTEMPT. OTHER: IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS REMOVED AND REPLACED DUE TO DISLODGMENT. REPOSITIONING WAS ATTEMPTED. HOWEVER, EVENTUALLY SCREW WOULD NOT RETRACT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: OTHER OPERATIONAL CONTEXT CONTRIBUTED TO EVENT. DISLODGED, RETRACT, FAILURE TO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS REMOVED AND REPLACED DUE TO DISLODGMENT. REPOSITIONING WAS ATTEMPTED. HOWEVER, EVENTUALLY SCREW WOULD NOT RETRACT. NO PATIENT COMPLICATIONS WERE 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 Required Intervention 5076 IMPLANTABLE PACING LEAD| SEDR01 IMPLANTABLE PULSE GENERATOR