BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2202215 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11295
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED WHETHER THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED OVERSENSING. THE LEAD WILL BE MONITORED, AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AN ALERT TRIGGERED AGAIN FOR A HIGH NUMBER OF SENSING INTEGRITY COUNTERS (SIC). HIGH RATE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES WERE ALSO NOTED. IT WAS DETERMINED THAT THERE WAS NO LEAD ISSUE, THE OVERSENSING IS ALL PHYSIOLOGIC DUE TO ATRIAL FLUTTER OCCASIONALLY BEING OVERSENSED. THE OVERSENSING RESULTED IN INHIBITION OF SENSING AND THE PATIENT'S HEART RATE WAS AT 30 BEATS PER MINUTE, WHICH WAS BELOW THE LOWER PROGRAMMED RATE. NO FURTHER 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other