BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 3031604 · Received April 2, 2013

    Report

    Report Number
    1028232-2013-00904
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    September 10, 2012
    Report Date
    March 25, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THERE ARE NO "PLATS" TO EXPLANT OR REVISE THIS LEAD. PACING MODE WAS CHANGED TO VVIR AND THE LEAD IS STABLE IN THE POCKET. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    ON (B)(6) 2012 PATIENT CAME INTO OFFICE WITH WEAKNESS. PATIENT HAD X-RAYS ON (B)(6) 2012 WHERE THE RADIOLOGIST NOTED LEADS IN POSITION. HOWEVER, UPON INSPECTION OF XRAY FILMS THE A-LEAD WAS NOTED TO BE COILED IN POCKED NEAR THE BATTERY DUE TO TWIDDLER'S SYNDROME. THIS LEAD REMAINS ACTIVELY IMPLANTED. THERE WAS NO INDICATION OF SURGICAL INTERVENTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135101 SETROX S 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other