BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 3070473 · Received April 22, 2013

    Report

    Report Number
    1028232-2013-01097
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 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

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. DURING THE VISUAL INSPECTION, CUTTINGS IN THE INSULATION WERE FOUND. IT IS REASONABLE TO ASSUME, THAT THE CUTTINGS RESULTED FROM THE EXPLANTATION PROCEDURE. BLOOD PENETRATED THE LEAD IN THE CUT AREAS. FURTHER ANALYSIS OF THE LEAD DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE ANALYSIS OF THE FIXATION MECHANISM PROVED TO BE WITHIN THE TECHNICAL SPECIFICATIONS. IN SUMMARY, THE LEAD PRESENTED CUTTINGS IN THE INSULATION, WHICH RESULTED PRESUMABLY FROM THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S RIGHT VENTRICULAR LEAD WAS REPOSITIONED SUCCESSFULLY DUE TO MICRODISLOGEMENT. THE PATIENT HAD A FALL WHICH CAUSED THE INCIDENT AND HAD SOME REACTIONS TO HIS MEDICATIONS. THE PHYSICIAN ADDED SOME SLACK TO THE ATRIAL LEAD TO PREVENT DISLODGEMENT. THERE WAS NO ALLEGATION AGAINST THE DEVICE FUNCTIONALITY. THIS LEAD REMAINS IMPLANTED. NO ADDITIONAL 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
    172448 DEXTRUS 4137 PACER LEAD NVN BIOTRONIK SE & CO. KG 358764

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization