BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812328 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16435
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    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
    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. THE LEAD INTEGRITY ALERT TRIGGERED. THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012. THERE WAS OVERSENSING WITH ELEVEN VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 210 MILLISECONDS ON (B)(6) 2012. THE VENTRICULAR SHORT INTERVAL COUNT IS EQUAL TO 331 COUNTS, IN 0.17 DAY, ON (B)(6) 2012.

    Description of Event or Problem · 1

    THE ANALYSIS WAS REVIEWED. THE LEAD TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. 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 SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD