BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA S DR

    MDR report key: 3864743 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11366
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 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
    MN, 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: 5076 LEAD IMPLANTED: (B)(6) 2003.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RECENT DEVICE REPLACEMENT PROCEDURE AND SUBSEQUENTLY AN ALERT WAS TRIGGERED FOR HIGH LEAD IMPEDANCE IN THE HIGH VOLTAGE COILS. A REAL TIME MEASUREMENT REVEALED IMPEDANCE VALUES WITHIN THE EXPECTED RANGE AND IT WAS INDICATED AS AN INTERMITTENT ISSUE. THE LEAD REMAINS IN USE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT APPEARED THAT THE SET SCREW FOR THE SVC COIL WAS NOT TIGHT. THE SET SCREW WAS TIGHTENED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338404 EVERA S DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DDBC3D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R 694758 LEAD