BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3860771 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05300
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 4196-88 IMPLANTABLE TACHY LEAD (B)(6) 2013; 5594-53 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK AND PRESENTED TO THE CLINIC. INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE WAS HIGH. DETECTIONS WERE TURNED OFF AND AN INTERVENTION WAS PLANNED FOR THE FOLLOWING WEEK. DURING THE INTERVENTION THE PHYSICIAN OBSERVED THAT THE CONNECTOR OF THE RV LEAD WAS LOOSE AND "CAME BACK WITHOUT OPENING THE SCREW". THE SYSTEM WAS RE-CONNECTED. THE PHYSICIAN CHECKED THE FINAL VALUES OVER THE DEVICE AND NO ANOMALIES WERE OBSERVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337413 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944A65

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization| L| R D294TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC