BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1991304 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02337
    Event Type
    Malfunction
    Date Received
    February 15, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 4 - VENTRICULAR NST=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2010 18:36:17 AND (B)(6) 2010 18:16:36. 3 - VF<=210 MS BETWEEN (B)(6) 2010 18:16:42 AND (B)(6) 2010 15:47:11. VENTRICULAR SHORT INTERVAL COUNT V-SIC=30.2 COUNTS AVG/DAY, IN 4.01 DAYS, BETWEEN (B)(6) 2010 13:06:28 AND (B)(6) 2010 13:22:57. VENTRICULAR SHORT INTERVAL COUNT V-SIC=333.8 COUNTS AVG/DAY, IN 136.03 DAYS, BETWEEN (B)(6) 2010 13:22:57 AND (B)(6) 2010 14:01:37. 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2010 06:19:33.

    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 THE LEAD EXHIBITED T-WAVE OVERSENSING. THE PATIENT REPORTS BEING A REGULAR USER OF COCAINE. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB