BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNOX SX 45-JBP

    MDR report key: 1890111 · Received October 29, 2010

    Report

    Report Number
    1028232-2010-02262
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BIOTRONIK SE & CO, KG
    Product Code
    DTB
    PMA / PMN Number
    K980869
    Adverse Event
    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 ACCOMPANYING 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 PATIENT WAS UNDERGOING A ROUTINE GENERATOR CHANGE DUE TO DEPLETION OF THE PULSE GENERATOR BATTERY. OBSERVATION OF THIS LEAD UNDER FLUOROSCOPY DEMONSTRATED A LEAD FRACTURE INCLUSIVE OF A WIRE PROJECTING FROM THE FRACTURE SITE. IT WAS FOUND THAT A STYLET WAS LEFT WITHIN THE LEAD'S INNER LUMEN. THIS LEAD WAS CAPPED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNOX SX 45-JBP PACER LEAD DTB BIOTRONIK SE & CO, KG 120438

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization