BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922481 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12960
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS DISTORTED. FURTHER TESTING REVEALED THAT SEVERAL CONDUCTORS WERE DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, AND THE LEAD APPEARED DAMAGED AT IMPLANT. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR IS DISTORTED IN THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THAT RIGHT VENTRICULAR REPLACEMENT LEAD HELIX WOULD NOT EXTEND. THE LEAD WAS NOT USED. ANOTHER LEAD WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THERE WERE 2311 MODE SWITCH EPISODES DUE TO ATRIAL OVERSENSING. THE LEAD REMAINS IN USE. 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 66 YR Other