BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2813621 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17037
    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/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE ACTUAL LEAD INVOLVED IN THE EVENT WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. SENSING/OVERSENSING: 12 - VENTRICULAR NST<(><<)>(><(><<)><(><<)>)>=216 MS ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 21:47:16 AND 22:53:24. 5 - LFP HIGH RATE-NS <(><<)>(><(><<)><(> <<)>)>= 190 MS AVERAGE V-CYCLE ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 09:33:26 AND 09:39:23. VENTRICULAR SHORT INTERVAL COUNT V-SIC=1398 COUNTS, IN 1.75 DAYS, BETWEEN (B)(6) 2012. LEAD INTEGRITY ALERT: 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 09:33:21. IMPEDANCE/HIGH IMPEDANCE: 2 - PATIENT ALERTS FOR OOT SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012. DAILY PACE IMPEDANCE TREND DATA, ABRUPT INCREASE FOR VENTRICULAR PACE BI IMPEDANCE=655 TO 4047 OHMS PEAK 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 CAREALERT TRIGGERED, AND THE LEAD EXHIBITED HIGH IMPEDANCES, NOISE, AND OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAREALERT TRIGGERED, AND THE LEAD EXHIBITED HIGH IMPEDANCES, NOISE, AND OVERSENSING. THE LEAD WAS EXPLANTED AND 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 S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB