BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152099 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05539
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. HOWEVER, THE PROXIMAL AND DISTAL CONDUCTORS OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED, THE DISTAL CONDUCTOR OF THE LEAD WAS OBSTRUCTED DUE TO A STYLET/GUIDEWIRE STUCK IN THE LUMEN, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH, THE INNER TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR, THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO PULLING/STRETCHING/OVERSTRESS AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE AND STRETCHING. IT WAS ALSO NOTED THAT THE HELIX WOULDN'T RETRACTED DUE TO LEAD HAS BEEN STRETCHED AND THERE WAS SEVERE EXPLANT DAMAGED DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: D154ATG IMPLANTABLE DEFIBRILLATOR (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SHORT V-V INTERVALS OBSERVED IN THE RIGHT VENTRICULAR (RV) LEAD AND IT WAS REPORTED TO SUGGEST POSSIBLE EARLY FAILURE OF THE LEAD. DURING THE PROCEDURE TO REMOVE THE RV LEAD, THE HELIX WOULD NOT RETRACT AND THE LEAD WAS EXTRACTED VIA LASER. IT WAS FURTHER REPORTED THAT DURING THE LASER EXTRACTION THE ATRIAL LEAD WAS ENTANGLED WITH THE RV LEAD AND INADVERTENTLY "PULLED OUT." THE RV LEAD AND ATRIAL LEAD WERE REPLACED WITH A NEW LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252939 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6949 IMPLANTABLE TACHY LEAD