BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1926588 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14414
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THE HELIX DISENGAGED FROM THE HELICAL CHANNEL. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEAD WAS BEING REPOSITIONED DUE TO A DILATED RIGHT VENTRICLE. ON THE THIRD ATTEMPT TO REPOSITION THE LEAD THE HELIX FAILED TO DEPLOY BECAUSE OF TISSUE ON THE TIP OF THE LEAD. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEAD WAS BEING REPOSITIONED DUE TO A DILATED RIGHT VENTRICLE. ON THE THIRD ATTEMPT TO REPOSITION THE LEAD, THE HELIX FAILED TO DEPLOY BECAUSE OF TISSUE ON THE TIP OF THE LEAD. THE LEAD WAS REMOVED AND REPLACED. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other