BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3153770 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06219
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY-THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND THAT THERE WERE 3 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(4) 2011 AND (B)(4) 2012. WEEKLY PACE IMPEDANCE TREND DATA SHOWS A DECREASE FOR MINIMUM A PACE= 264 TO 160 OHMS RANGE BETWEEN (B)(4) 2011 AND (B)(4) 2013. WEEKLY PACE LEAD TREND DATA SHOWS AN INCREASE FOR MINIMUM AND MAXIMUM RIGHT VENTRICULAR PACE= 316 TO 856 OHMS PEAK BETWEEN (B)(4) 2012 AND (B)(4) 2013. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4) DEFIBRILLATOR 2008 (B)(6); 5076-52 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCREASE IN RIGHT VENTRICULAR (RV) PACING THRESHOLD AND IMPEDANCE. THE PHYSICIAN ATTEMPTED TO IMPLANT ANOTHER RV LEAD HOWEVER WAS NOT ABLE TO DUE TO THE PATIENT'S ANATOMY. A DIFFERENT LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255286 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R