BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 3232177 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01958
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    May 28, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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

    OUS MDR - BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED INCREASED PACING THRESHOLD MEASUREMENTS SHORTLY AFTER IMPLANT. AN X-RAY DID NOT CONFIRM DISLODGEMENT, BUT THE BODY OF THE LEAD HAD MOVED A LITTLE. MICRO-DISLODGEMENT WAS SUSPECTED. THE PACING OUTPUTS WERE INCREASED. TWO DAYS LATER, THE PACING THRESHOLDS HAD INCREASED AGAIN, TO 5.5V AT 0.4MS SO THE LEAD WAS REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE WITHOUT FURTHER COMPLICATIONS. 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
    331085 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 360314

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization