BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812237 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16916
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 19, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED 2 PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012, AS WELL AS 9 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 210 MS BETWEEN (B)(6) 2012. THERE WERE ALSO 5 LEAD FAILURE PREDICTOR HIGH RATE NON-SUSTAINED EPISODES WITH AN AVERAGE VENTRICULAR CYCLE LENGTH LESS THAN OR EQUAL TO 212 MS ON (B)(6) 2012. THE VENTRICULAR SHORT INTERVAL COUNT WAS 404 COUNTS IN THE 3.8 DAYS BETWEEN (B)(6) 2012.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SEVERAL NON-SUSTAINED TACHYCARDIA (NST) EPISODES AND OVERSENSING. PERFORMANCE DATA WAS COLLECTED AND ANALYZED AND ANALYSIS REVEALED HIGH IMPEDANCE AND NOISE ON THE ELECTROGRAM (EGM). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SEVERAL NON-SUSTAINED TACHYCARDIA (NST) EPISODES AND OVERSENSING. PERFORMANCE DATA WAS COLLECTED AND ANALYZED AND ANALYSIS REVEALED HIGH IMPEDANCE AND NOISE ON THE ELECTROGRAM (EGM). 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB