BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2695540 · Received August 14, 2012

    Report

    Report Number
    2649622-2012-09573
    Event Type
    Injury
    Date Received
    August 14, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. PROGRAMMER DATA SHOWS A LEAD INTEGRITY ALERT TRIGGERED ON (B)(6) 2010 20:40:41. A PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE TRIGGERED ON (B)(6) 2010 20:40:41. ONE VENTRICULAR NONSUSTAINED TACHYCARDIA (NST) EPISODE OF 160 MS OCCURRED ON (B)(6) 2010 20:40:41. VENTRICULAR SHORT INTERVAL COUNT V-SIC=23.6 COUNTS AVG/DAY, IN 34.80 DAYS, OCCURRED BETWEEN (B)(6) 2010 14:19:39 AND (B)(6) 2010 09:35:38.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONTACTED THE HOSPITAL DUE TO THE SOUND OF THE LEAD INTEGRITY ALERT (LIA). THE LEAD WAS ALSO REPORTED TO HAVE DISPLAYED OVERSENSING, HIGH IMPEDANCE, AND DECREASING AND LOW IMPEDANCE VALUES. THE DEVICE WAS RE-PROGRAMMED. THE LEAD WAS SUBSEQUENTLY REPLACED. THE PATIENT IS ENROLLED IN THE ADVANCE III STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS 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 41 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB