BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2943810 · Received January 31, 2013

    Report

    Report Number
    1028232-2013-00157
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 18, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    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 THAT THIS LEAD WAS EXPLANTED DUE TO A CONCERN THAT ITS HELIX PERFORMANCE WAS COMPROMISED. THE LEAD WAS THOUGHT TO BE DISLODGED DUE TO A POORLY SECURED SUTURE SLEEVE. THE INSULATION OF THIS LEAD WAS PURPOSEFULLY CUT IN ORDER TO USE IF FOR INTRODUCING A NEW WIRE SO A NEW SAFE SHEATH COULD BE INTRODUCED. A REPLACEMENT LEAD WAS THEN SUCCESSFULLY IMPLANTED IN THE PATIENT. THE LEAD WILL NOT BE COMING BACK FOR ANALYSIS AS IT WAS DISPOSED OF BY THE HOSPITAL STAFF BEFORE A RETURN REQUEST COULD BE SENT OUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42829 DEXTRUS 4137 PACER LEAD DTB BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization