BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203728 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11892
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE LEAD WAS STRETCHED. IT WAS NOTED THAT THE INNER INSULATION WAS KINKED/BUCKLED AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE LEAD HAS BEEN STRETCHED CAUSING THE INNER TUBING TO BUCKLE. THIS PREVENTS PROPER TORQUE TRANSFER WHEN TURNING THE IS-1 PIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL IMPLANT, THE RIGHT VENTRICULAR LEAD HAD RESISTANCE IN ADVANCING AND POSITIONING. THRESHOLDS WERE HIGH AFTER SEVERAL ATTEMPTS AT PLACEMENT. THE LEAD WAS THEN DIFFICULT TO REMOVE. ONCE REMOVED, IT WAS NOTED THAT THERE WAS A SMALL AREA NEAR THE RING WHERE THE INSULATION APPEARED COMPROMISED. THE LEAD WAS NOT USED, AND A NEW LEAD IMPLANTED. 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 95 YR Other