BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2810886 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16561
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 20, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4). THE FULL LEAD WAS RETURNED, ANALYZED, AND THE HELIX WAS DISTORTED/BENT. IT WAS ALSO NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE DEFIBRILLATION CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS TORN, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST ALSO NOTED THAT THE RV EXPOSED DEFIBRILLATION CONDUCTOR SLIGHTLY DISTORTED AT 58CM PASSED THROUGH THE INTRODUCER WITHOUT ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD WAS ATTEMPTED BUT NOT USED DUE TO POSSIBLE LEAD DAMAGE AS THE PATIENT'S SUBCLAVIAN PRESENTED WITH A HARD CURVE. THE THRESHOLD AND IMPEDANCE ON THE LEAD WAS HIGH AT EACH PLACEMENT WITH UNSTABLE R-WAVE DETECTION. ANOTHER LEAD WAS IMPLANTED. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other