BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA S DR

    MDR report key: 3993813 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14575
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 PRODUCT: 407652 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED CARDIAC ARREST IN THE FIELD AND WAS REVIVED BY ADMINISTRATION OF CPR. THE DURATION OF THE ARREST WAS NOT DETERMINED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MEDICAL INTERVENTION AND SUPPORT. REVIEW OF STORED DEVICE DATA FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVEALED THAT THE PATIENT HAD DEVELOPED TORSADES DE POINTES RESULTING IN VENTRICULAR FIBRILLATION (VF) EPISODES THAT DID NOT MEET THE PROGRAMMED DETECTION PARAMETERS. AS A RESULT NO THERAPY HAD BEEN DELIVERED. IT WAS ALSO REPORTED THAT AT SOME POINT THE PATIENT HAD EXPERIENCED A CHOKING EPISODE THAT WAS PRECEDED BY RECORDED NON-SUSTAINED TACHYCARDIA EPISODES. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469023 EVERA S DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBC3D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| L| R 694765 LEAD