BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4500148 · Received February 10, 2015

    Report

    Report Number
    2649622-2015-01063
    Event Type
    Injury
    Date Received
    February 10, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 16, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. PRODUCT EVENT SUMMARY: PERFORMANCE INFORMATION WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). EIGHT NON-SUSTAINED TACHYCARDIA (NST) EPISODES WITH V-V INTERVALS <(><<)>200 MS OCCURRED BETWEEN (B)(4) 2014. 41 SIC/DAY SINCE LAST SESSIONS 2 DAYS BEFORE. LEAD FAILURE PREDICTOR TRIGGERED ON (B)(4) 2014 FOR V-SICS AND NSTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ALSO NOISE NOTED WHEN THE PATIENT LAID ON THEIR STOMACH. 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
    97580 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R 5076-45 LEAD, D334TRG