BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA XT VR

    MDR report key: 4251433 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21610
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2014. OF NOTE, THE REPORTABLE MALFUNCTION AND SERIOUS INJURY (DISLODGEMENT AND CARDIAC ARREST) IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT SHOULD HAVE BEEN SUBMITTED ON (B)(6) 2014. INFORMATION WAS SUBSEQUENTLY RECEIVED ON 2014-10-20 AND REVEALED THE PATIENT DIED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BI-MONTHLY REPORTING AND IS THEREFORE BEING SUBMITTED AS A 30-DAY REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO EMERGENCY ROOM (ER) AFTER VENTRICULAR FIBRILLATION AND CARDIAC ARREST. CARDIO-PULMONARY RE SUSCITATION WAS PROVIDED TO THE PATIENT. MULTIPLE SHOCKS FAILED TO CONVERT THE ARRHYTHMIA AND EXTERNAL DEFIBRILLATION WAS REQUIRED. X-RAY AND FLUOROSCOPY REVEALED THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE LEAD ALSO EXHIBITED HIGH THRESHOLDS, LOW PACING IMPEDANCE, AND DIMINISHED SENSING. THE LEAD WAS REMOVED AND REPLACED, HOWEVER IT WAS LATER REPORTED BY A FAMILY MEMBER THAT THE PATIENT DIED DUE TO BRAIN DAMAGE THAT OCCURRED FROM THE EVENT AND BLAMED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737517 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DVBB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Death| H| L| R 6947 LEAD