BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2213014 · Received August 9, 2011

    Report

    Report Number
    1028232-2011-01782
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    June 15, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT THAT DURING A ROUTINE DEVICE CHECK, THE PHYSICIAN STATED THAT ONE OF THE LEADS WAS DISCONNECTED. IT WAS REPORTED THAT THE PHYSICIAN PLANNED TO PERFORM A REVISION AT A LATER DATE AS ONE OF THE LEADS WAS STILL WORKING AND THE PHYSICIAN FELT THAT THE PATIENT DIDN'T NEED THE PACEMAKER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE HAS BEEN CONTACTED TO TRY TO CLARIFY WHETHER THE PATIENT MEANT LEAD DISLODGEMENT OR A LEAD/DEVICE CONNECTION ISSUE. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other