BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4162571 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12694
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 INDICATES THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. THERE WAS A LEAD IMPEDANCE OUT OF RANGE ALERT. THE IMPEDANCE TREND ON THE SVC DEFIBRILLATION COIL WAS VARIABLE. IT WAS NOTED THAT AN OUT OF TOLERANCE SUB-THRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(6) 2014. MAXIMUM SVC DEFIBRILLATION IMPEDANCE RISES FROM 284 OHM THE WEEK ENDING (B)(6) 2014 TO GREATER THAN 12000 OHM THE WEEK ENDING (B)(6) 2014.

    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).

    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 INTERMITTENT HIGH IMPEDANCE IN THE SUPERIOR VENA CAVA (SVC) SHOCK COIL. THE LEAD WAS SUSPECT OF A POSSIBLE FRACTURE. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644929 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R D154AWG ICD, 5076-52 LEAD