BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNOX SX 53/15-BP

    MDR report key: 3083076 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01161
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    K980869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THIS LEAD WAS CAPPED AND REPLACED DUE TO AN EXTERNAL COIL LEAD FRACTURE. THE DEVICE WAS CHANGED OUT AT THE SAME TIME DUE TO ERI CAUSED BY THE DEVICE BEING PROGRAMMED AT HIGH OUTPUTS IN UNIPOLAR. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183665 SYNOX SX 53/15-BP PACER LEAD DTB BIOTRONIK SE & CO. KG 124853

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization