BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790295 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14723
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    June 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THAT APPROXIMATELY A MONTH AND A HALF POST IMPLANT, THE PATIENT RECEIVED A VIBRATORY PATIENT ALERT FOR THE RIGHT VENTRICULAR (RV) LEAD HAVING HIGH IMPEDANCE. THE IMPEDANCE RANGED FROM 390 TO 2075 OHMS. ALSO, THERE WAS AN EPISODE OF NOISE DETECTED WHICH RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY AND AN ABORTED SHOCK THERAPY. ROUGHLY ONE WEEK LATER, THE RV LEAD IMPEDANCE MEASURED OUT OF RANGE AND THE PATIENT WAS SEEN BY THE CLINIC FOR TROUBLESHOOTING WHERE NO ISSUES WERE FOUND AND ALL OF THE IMPEDANCE VALUES WERE IN RANGE. THE RV LEAD WILL CONTINUE TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS OVERSENSING OF NOISE ON THE LEAD. THE NOISE RESULTED IN AN ABORTED SHOCK. IT WAS NOTED THAT DURING THE NOISE EPISODE, IT WAS ALSO OBSERVED THAT THE R-WAVE AMPLITUDE ON THE EGM (ELECTROGRAM) WAS ATTENUATED. 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other CD1231 COMPETITOR IMPLANTABLE CARDIO/DEFIB