BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812648 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03770
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS 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. OVERSENSING WAS NOTED WITH TWO VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES EQUAL TO 210 MS ON (B)(6) 2012. AND THERE WERE TEN VENTRICULAR FIBRILLATION EPISODES LESS THAN OR EQUAL TO 210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2010 AND (B)(6) 2012.

    Description of Event or Problem · 1

    DEVICE PRODUCT PERFORMANCE INFORMATION WAS RECEIVED BY THE MANUFACTURER AND ANALYZED. THE ANALYSIS NOTED OVERSENSING ON THE RIGHT VENTRICULAR LEAD. FOLLOW UP INFORMATION WAS RECEIVED THAT INDICATED THAT THERE HAD BEEN NO PRODUCT PERFORMANCE ISSUES NOTED WITH THE LEAD. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 2187 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD