BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2953526 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01239
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS ANALYSIS FOUND THAT THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. PRODUCT ID: 407652, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT ID: D154ATG, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). 4076 IMPLANTABLE PACING LEAD 2005 (B)(6).

    Additional Manufacturer Narrative · 1

    WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. HIGH RESISTANCE/IMPEDANCE WAS NOTED WITH THREE PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2012 AND (B)(6) 2013. THE WEEKLY PACE LEAD TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MAXIMUM RIGHT VENTRICULAR PACE= 408 TO 1728 OHMS RANGE BETWEEN (B)(6) 2011 AND (B)(6) 2012. OVERSENSING AS NOTED WITH THIRTEEN VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES<(><<)>=210 MS BETWEEN (B)(6) 2013. INTERFERENCE/NOISE WAS NOTED WITH A VENTRICULAR SHORT INTERVAL COUNT V-SIC=2011 COUNTS, IN 27.25 DAYS, BETWEEN (B)(6) 2013.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SHORT INTERVAL COUNT OF 6400 SINCE (B)(6) 2012. THERE WAS AN EPISODE IN (B)(6) 2012 WHERE THE LEAD DELIVERED A SHOCK DUE TO NON-PHYSIOLOGIC SENSING, MOST LIKELY ELECTROMAGNETIC INTERFERENCE. AROUND THAT SAME TIME, THE RV PACING IMPEDANCE FLUCTUATED. HOWEVER, IN THE PAST SEVERAL WEEKS, THE IMPEDANCE TREND HAS BEEN STABLE. IT WAS NOTED THAT WHEN POCKET MANIPULATION WAS DONE AND SIMULTANEOUS MEASUREMENTS WERE TAKEN, THERE WAS ONE ELEVATED MEASUREMENT. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD HAD OCCASIONAL HIGH IMPEDANCE AND A POSSIBLE FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56719 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| L| R D154ATG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR