BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2201794 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11203
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 17, 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
    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. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED 2 - PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011 23:08:41 AND (B)(6) 2011 07:51:07. SENSING - OVERSENSING 2 - VENTRICULAR NST<=180 MS AVERAGE V-CYCLE ON (B)(6) 2011 14:21:01 AND (B)(6) 2011 07:51:06. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=11.7 COUNTS AVG/DAY, IN 3.41 DAYS, BETWEEN (B)(6) 2011 22:05:16 AND (B)(6) 2011 07:52:07.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD INTEGRITY ALERT TRIGGERED TWICE IN A WEEK DUE TO NOISE, INCREASED SENSING INTEGRITY COUNTS AND NON-SUSTAINED TACHYCARDIA EPISODES ON THE RIGHT VENTRICULAR PACE/SENSE PORTION. THE LEAD INTEGRITY ALERT WAS TURNED OFF AND 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 PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other 4196 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB