BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1922880 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13121
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (RIGHT VENTRICULAR) IMPEDANCE INCREASED TO GREATER THAN 2500 OHMS, AND THE THRESHOLD INCREASED TO 2.0V. BECAUSE THE PATIENT WAS (B)(6), THE PACING THRESHOLD WAS STILL ACCEPTABLE, AND THE HV (HIGH VOLTAGE) COIL IMPEDANCE WAS OK, THE PHYSICIAN ELECTED TO LEAVE THE LEAD IN USE, WITH NO INVASIVE INTERVENTION. THE RV IMPEDANCE ALERT WAS TURNED OFF TO PREVENT IT FROM SOUNDING EVERY DAY, AND FOLLOW-UP WAS SCHEDULED FOR THE NEXT MONTH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB