BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1792604 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07043
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    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) NO ANOMALIES WERE FOUND. THE DISTAL CONDUCTOR WAS DISTORTED, HELIX BENT, AND BLOOD ON THE HELIX. THE LEAD INSULATION IS TWISTED DUE TO TURNING THE CONNECTOR PIN AND THE HELIX NOT RETRACTING. THIS IS DUE TO THE DISTORTED COIL IN THE CONNECTOR. THE FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED WITH NO INFORMATION, BUT APPEARS TO AN ATTEMPTED BUT NOT IMPLANTED LEAD. WE WILL CONDUCT FOLLOW-UP TO DETERMINE WHY THE LEAD WAS NOT USED. 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 64 YR Required Intervention