BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3864738 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07549
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINE IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. PRODUCTS: (B)(4) ICD IMPLANTED: 2013 (B)(6); 383059 LEAD IMPLANTED: 2010 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THIS DATA INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) AND THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING. IT WAS NOTED THAT ON (B)(4) 2014: ON (B)(4) 2014: LEAD INTEGRITY ALERT TRIGGERED DUE TO NST (NON-SUSTAINED TACHYCARDIA) EPISODES AND SIC (SHORT INTERVAL COUNTS) OF 190, THE LEAD IMPEDANCE INCREASED FROM 380 TO 912 AND LEAD NOISE WAS NOTED ON EGM (ELECTROGRAM).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. THE RIGHT VENTRICULAR (RV) LEAD HAD AN INCREASE IN PACE/SENSE IMPEDANCES, OVERSENSING, AND EPISODES WITH NOISE. LEAD FRACTURE IS SUSPECTED. IT WAS ALSO NOTED THAT IT COULD POSSIBLY BE A CONNECTION OR HEADER ISSUE. THE LEAD AND DEVICE WERE 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
    337761 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R 419688 LEAD