BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964581 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02156
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCT: 5071 X2 IMPLANTABLE PACING LEADS (B)(6) 2009; 5076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT FOR THE RIGHT VENTRICULAR (RV) LEAD SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE BEING OUT OF RANGE. THE IMPEDANCE WAS UNSTABLE AND WAS RANGING FROM UNABLE TO MEASURE TO GREATER THAN 200 OHMS AND SOME MEASUREMENTS WERE NORMAL. IT WAS INDICATED THAT DEFIBRILLATION THRESHOLD TESTING WAS DONE ON THE PATIENT, AND THE PATIENT HAD TO BE DEFIBRILLATED EXTERNALLY. THE SVC PORTION OF THE RV LEAD WAS CAPPED AND REPLACED AND THE REST OF THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69047 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR