BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2811092 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15831
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THAT THERE WAS HIGH RESISTANCE/IMPEDANCE. THERE WAS ONE PATIENT ALERT FOR OUT OF TOLERANCE LEAD IMPEDANCE ON (B)(6) 2012 09:00:04. THE PROGRAMMER S2D DATA FILE (B)(4) SHOWS ONE ALERT EVENT FOR "SVC DEFIB LEAD IMPEDANCE GREATER THAN 200 OHMS ON (B)(6) 2012 09:00:04.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ALARM WAS TRIGGERED AS THE RIGHT VENTRICULAR LEAD'S SVC (SUPERIOR VENA CAVA) IMPEDANCE WAS HIGH. IT WAS NOTED THAT REPEATED SVC MEASUREMENTS VARIED. THE PHYSICIAN SUSPECTED THE COILS TO BE FRACTURED. THE LEAD WAS CAPPED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD