BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2130884 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10286
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 22, 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
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX WAS DISTORTED/BENT. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD) AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE HELIX WILL NOT EXTEND AND RETRACT AT THIS TIME DUE TO THE LEAD BEING RETURNED WITH DAMAGED HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, IT WAS OBSERVED THAT THE RIGHT VENTRICULAR LEAD HELIX GOT STUCK. THE HELIX SEEMED TO BE DEFORMED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other