BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951761 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00206
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    December 1, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT PRODUCTS: 4195 IMPLANTABLE PACING LEAD 2008 (B)(6), 5554 IMPLANTABLE PACING LEAD 1999 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT TRIGGERED DUE TO ELEVATED RIGHT VENTRICULAR (RV) PACE/SENSE IMPEDANCE. THE RV PACING IMPEDANCE HAS DEMONSTRATED GRADUALLY RISING IMPEDANCE SINCE IMPLANT. RECENTLY THE IMPEDANCE HAS BEEN MORE VARIABLE AND NOT STEADY. A POSSIBLE RV LEAD FRACTURE IS SUSPECTED. THE DEVICE WAS REPROGRAMMED AND THE 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
    56926 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR