BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 1926455 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14329
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 THERE WAS A LEAD INTEGRITY ALERT, THREE HIGH IMPEDANCE PEAKS IN THE LEAD IMPEDANCE TREND, MORE THAN 400 SHORT VENTRICULAR INTERVALS IN THE PAST APPROXIMATELY ONE WEEK, AND TWO NON-SUSTAINED VENTRICULAR TACHYCARDIA RECORDED EPISODES. THE PHYSICIAN SUSPECTED NOISE ("EXTERNAL INTERFERENCE") BUT ALSO WAS CONCERNED ABOUT THE POSSIBILITY OF A LEAD INTEGRITY ISSUE. THE LEAD IS STILL 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB