BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 60

    MDR report key: 2844882 · Received November 2, 2012

    Report

    Report Number
    1028232-2012-02769
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD 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 LEAD 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. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE PT WAS NOTED TO HAVE OVERSENSING ON THE RV CHANNEL WHICH INHIBITED PACING. THE PHYSICIAN TRIED REPLACING THE RV LEAD BUT SIMILAR ISSUES WERE NOTED. THE EVENT COULD NOT BE REPRODUCED. THE PHYSICIAN REPLACED THE PACEMAKER AND THE ISSUE WAS NOT SEEN WITH THE NEW DEVICE AND NEW RV LEAD. THIS LEAD WAS EXPLANTED AND RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization