BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2053234 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05814
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 1, 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
    OR, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THERE WAS BLOOD IN/ON HELIX MECHANISM. IT WAS ALSO NOTED THAT THE HELIX WAS DISTORTED/BENT AND THAT THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH FULLY EXTENDED AND STRETCHED HELIX.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THE HELIX WAS DISTORTED/BENT. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON HELIX MECHANISM AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH FULLY EXTENDED AND STRETCHED HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT ATTEMPT THE RIGHT VENTRICULAR LEAD WAS REPOSITIONED TWICE TO GET ACCEPTABLE NUMBERS, BUT AFTER THE SECOND HELIX RETRACTION IT WAS NOT ABLE TO BE RE-EXTENDED. THE LEAD WAS REMOVED AND REPLACED. ONCE ON THE TABLE THE HELIX WAS ABLE TO BE EXTENDED, BUT IT TOOK MANY TURNS, AND THE HELIX APPEARED "BENT." NO PATIENT COMPLICATIONS WERE 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 56 YR Other