BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2122208 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07841
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS. ANALYSIS FOUND THAT THE DISTAL CONDUCTOR WAS FRACTURED, THAT THE INNER TUBING WAS KINKED/BUCKLED, THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THAT THE HELIX/LOBE WAS DISTORTED/BENT AND THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE ANALYST ALSO OBSERVED THAT THE LEAD APPEARED TO HAVE BEEN IMPLANTED WITH A BEND IN IT AT THE FRACTURE SITE.

    Description of Event or Problem · 1

    THE RIGHT VENTRICULAR LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. 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 76 YR Hospitalization| R