BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2454867 · Received February 16, 2012

    Report

    Report Number
    2649622-2012-01528
    Event Type
    Injury
    Date Received
    February 16, 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
    IT
    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. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2011 23:27:41. SENSING - OVERSENSING 10 - VENTRICULAR NST<=215 MS BETWEEN (B)(6) 2011 23:28:17 AND (B)(6) 2011 00:56:05. 5 - LFP HIGH RATE-NS <= 205 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2011 21:36:28 AND (B)(6) 2011 05:55:00. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE 3 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2011 03:00:17 AND (B)(6) 2011 03:00:13. PROGRAMMER S2D DATA SHOWS 3 - ALERTS FOR RV BIPOLAR LEAD IMPEDANCE > 3000 OHMS BETWEEN (B)(6) 2011 03:00:17 AND (B)(6) 2011 03:00:13.

    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. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4)2011 23:27:41. SENSING - OVERSENSING 10 - VENTRICULAR NST<=215 MS BETWEEN (B)(4) 2011 23:28:17 AND (B)(4) 2011 00:56:05. 5 - LFP HIGH RATE-NS <= 205 MS AVERAGE V-CYCLE BETWEEN (B)(4) 2011 21:36:28 AND (B)(4) 2011 05:55:00. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE 3 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(4) 2011 03:00:17 AND (B)(4) 2011 03:00:13. PROGRAMMER S2D DATA SHOWS 3 - ALERTS FOR RV BIPOLAR LEAD IMPEDANCE > 3000 OHMS BETWEEN (B)(4) 2011 03:00:17 AND (B)(4) 2011 03:00:13.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD NOISE AND UNSTABLE IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WERE NON-SUSTAINED TACHYCARDIA EPISODES POSSIBLY DUE TO NOISE. THE LEAD WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE AND UNSTABLE IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WERE NON-SUSTAINED TACHYCARDIA EPISODES POSSIBLY DUE TO NOISE. IT WAS LATER REPORTED THAT THE RV LEAD ALSO HAD HIGH IMPEDANCE AND OVERSENSING WHICH TRIGGERED AN ALERT. THE LEAD WILL BE REPLACED. 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 Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB