BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3021911 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00831
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 25, 2013
    Report Date
    March 15, 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 DEVICE WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL INSPECTION SHOWED CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE OUTER COIL. BASED ON THE SYMPTOMS, IT IS REASONABLE TO ASSUME THAT THESE DAMAGES RESULTED FROM THE EXPLANT PROCEDURE. FURTHER ANALYSIS OF THE LEAD DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED DISLODGMENT. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE MECHANICAL ANALYSIS OF THE FIXATION MECHANISM WERE INVESTIGATED. NO PECULIARITIES WERE FOUND. IN SUMMARY, CUTTINGS IN THE INSULATION AND DEFORMATIONS OF THE OUTER COIL WERE OBSERVED, WHICH RESULTED MOST LIKELY FROM THE EXPLANT 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 A REVISION PROCEDURE WAS PERFORMED DUE TO A RIGHT VENTRICULAR LEAD DISLODGEMENT. DURING THE PROCEDURE THE PHYSICIAN THOUGHT THERE MIGHT BE TISSUE IN THE HELIX, THUS THE LEAD WAS EXPLANTED. THE SURGEON OPTED TO CUT THE INSULATION ON THE EXPLANTED LEAD AND USE IT TO GAIN ACCESS FOR THE NEW LEAD. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123585 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization