BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2790336 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15320
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED OVERSENSING. THERE WERE FIVE LEAD FAILURE PREDICTOR (LFP) HIGH RATE NON-SUSTAINED (NS) EPISODES LESS THAN OR EQUAL TO 205 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2012, 17:08:14 AND (B)(6) 2012, 18:52:44. THERE WAS ONE VENTRICULAR FIBRILLATION (VF) EPISODE EQUAL TO 130 MS AVERAGE V-CYCLE ON (B)(6) 2012, 19:22:21. A LEAD INTEGRITY ALERT WAS TRIGGERED; THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012, 14:25:32.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING. A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR AN INCREASED SENSING INTEGRITY COUNT (SIC) AND TWO FAST NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED AND THE HIGH VOLTAGE PORTION 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB