BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2123898 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-08026
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PROXIMAL SEGMENT OF THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD AN ALERT TONE FOR HIGH IMPEDANCE AND THAT THE SUPERIOR VENA CAVA HIGH VOLTAGE COIL OF THE LEAD WAS APPARENTLY FRACTURED. THE LEAD WAS CAPPED 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD| 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD