BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2980976 · Received February 19, 2013

    Report

    Report Number
    1028232-2013-00379
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    December 12, 2012
    Report Date
    February 8, 2013
    Manufacturer
    BIOTRONIKSE & 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

    OUS MDR - THE LEADS WERE NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THESE PARTICULAR LEADS. THE MANUFACTURING PROCESS FOR THESE LEADS 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 LEADS WERE NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR LEAD MANUFACTURING.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF 9 MONTHS IT WAS REPORTED THAT THE PATIENT WITH THESE LEADS EXPERIENCED A PRE-SYNCOPAL EPISODE. NOISE WAS DETECTED ON THE RIGHT VENTRICULAR AND RIGHT ATRIAL CHANNELS UPON REVIEWING AN ELECTROGRAM. THE LEAD MEASUREMENTS WERE WITHIN RANGE AND AN X-RAY REVEALED NO LEAD DAMAGE. NO FURTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE DEVICE HAS BEEN REPROGRAMMED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72191 DEXTRUS 4137 PACER LEAD DTB BIOTRONIKSE & CO. KG 360313

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization