BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2203637 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12590
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD IT WAS INITIALLY PLACED IN THE RV APEX AND ACHIEVED GOOD PACING AND SENSING MEASUREMENTS. HOWEVER, AFTER PLACING THE ATRIAL LEAD, THE PHYSICIAN RE-CHECKED THE RV LEAD AND THE R-WAVES HAD DROPPED. THE RV LEAD WAS REPOSITIONED USING A PURPLE STYLET WHICH THEN COULD NOT BE REMOVED FROM THE LEAD WHILE THE LEAD WAS IN THE RIGHT VENTRICLE (RV.) THE RV LEAD APPEARED TO BE BUCKLING AT THE DISTAL END OF THE LEAD AS TENSILE FORCE WAS APPLIED TO THE STYLET. IT WAS ALSO REPORTED THAT ONCE THE RV LEAD WAS REMOVED FROM THE BODY, THE STYLET COULD BE REMOVED FROM THE LEAD. THE RV LEAD WAS NOT USED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other