BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2952297 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00515
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    February 26, 2009
    Report Date
    February 22, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION; HOWEVER, WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE POSITIONING THE RIGHT VENTRICULAR (RV) LEAD, A VENTRICULAR TACHYCARDIA OCCURRED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE DISCOVERY CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55819 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening D29$VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC