BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3940510 · Received July 17, 2014

    Report

    Report Number
    2649622-2014-07651
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2014. OF NOTE, THE REPORTABLE SERIOUS INJURY (POSSIBLE PERFORATION ) IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT SHOULD HAVE BEEN SUBMITTED ON (B)(6) 2014. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(6) 2014 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE LEAD HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEAD CAUSED A POSSIBLE MYOCARDIUM PERFORATION CAUSING TAMPONADE. THE PROCEDURE WAS ABORTED AND THE PATIENT UNDERWENT THORACIC SURGERY. IT WAS LATER REPORTED THAT THE PATIENT DIED LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418896 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Death