BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203019 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11618
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND PRIMARY ANALYSIS REVEALED THAT THE OUTER INSULATION WAS BREACHED CUT. THE OUTER INSULATION WAS ALSO MELTED AND THE HELIX/LOBE WAS DISTORTED/BENT. THERE WAS ALSO APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND THE ATRIAL LEAD DISLODGED. UPON INSPECTION, IT WAS NOTED THAT THE RV LEAD HAD BEEN "STITCHED THROUGH THE INSULATION". THE RV LEAD WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD WAS REPOSITIONED AND IS STILL IN USE. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R ADDR01 IMPLANTABLE PACEMAKER/CARDIO/DEFIBRILLATOR