BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811666 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15879
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    March 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THERE WAS A LEAD WARNING DUE TO LOW IMPEDANCE MEASUREMENTS ON THE HIGH VOLTAGE COILS OF THE RIGHT VENTRICULAR (RV) LEAD. OVERSENSING WAS ALSO NOTED ON THE LEAD. IN ADDITION, THE ATRIAL AND RV PACING LEAD IMPEDANCE MEASUREMENTS WERE HIGH. TECHNICAL SERVICES DEPARTMENT WAS CONTACTED AND IT WAS RECOMMENDED THE DEVICE BE REPLACED. FOLLOW UP WAS CONDUCTED WITH THE PHYSICIAN'S OFFICE TO OBTAIN ADDITIONAL INFORMATION ON THE PATIENT AND THE DEVICE, BUT THE ATTEMPTS WERE UNSUCCESSFUL. RECORDS INDICATE THE DEVICE AND LEADS REMAIN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other D314TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4583 COMPETITOR IMPLANTABLE PACING LEAD