BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3618047 · Received February 8, 2014

    Report

    Report Number
    2649622-2014-02096
    Event Type
    Injury
    Date Received
    February 8, 2014
    Date of Event
    November 15, 2013
    Report Date
    November 18, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: A 407652 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) AND THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. 4 NON-SUSTAINED TACHYCARDIA , 1 VENTRICULAR FIBRILLATION (VF), 4 T-WAVE OVERSENSING (TWOS), AND 5 "LEAD FAILURE PREDICTOR" EPISODES OF LESS THAN 220 MS CYCLE LENGTH ARE RECORDED ON (B)(6) 2013. 66 LIFETIME V-SIC OCCUR SINCE (B)(6) 2013. LEAD INTEGRITY ALERT (LIA) TRIGGERED ON (B)(6) 2013 DUE TO MEETING THE CONDITIONS FOR NON-SUSTAINED TACHYCARDIA AND V-SIC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCKS AS THE RIGHT VENTRICULAR (RV) LEAD HAD EPISODES OF T-WAVE OVERSENSING (TWOS) . THE LEAD SENSITIVITY WAS ADJUSTED AND THE LEAD 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
    82105 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Life Threatening| R D314DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR