BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2201648 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11156
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 12, 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
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE PHYSICIAN HAD DIFFICULTIES WITH DISLODGEMENT AND POSITIONING OF THE RIGHT VENTRICULAR LEAD (RV) DUE TO THE PATIENT'S ANATOMY. OVERSENSING IN THE FORM OF VENTRICULAR TACHYCARDIA EPISODES WERE NOTED ON THE ELECTROCARDIOGRAM AS WELL AS UNDER SENSING IN THE FORM OF ASYSTOLE. THE RV LEAD IMPLANT ATTEMPT WAS ABANDONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    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 87 YR Other (B)(4) COMPETITOR IMPLANTABLE PACING LEAD