BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4136

    MDR report key: 3002196 · Received March 13, 2013

    Report

    Report Number
    1028232-2013-00638
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 18, 2013
    Report Date
    March 1, 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. ITS PERFORMANCE WAS SCRUTINIZED, INCLUDING A VISUAL, ELECTRICAL AND MECHANICAL INSPECTION. THE VISUAL ANALYSIS DEMONSTRATED THAT THE LEAD'S DISTAL PART WAS PULLED OUT OF THE RING ELECTRODE. THEREFORE, THE ADHESIVE RESIDUALS ON THE JOINING SURFACE OF LEAD TIP AND THE LEAD BODY WERE ANALYSED. THE ANALYSIS REVEALED NO INDICATION OF A MATERIAL OR A MANUFACTURING PROBLEM. AS THE ROOT CAUSE OF THE OBSERVED DAMAGE TRACTION FORCES DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. CUTTINGS OF THE INSULATION OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. IN THE COURSE OF THE ANALYSIS, NO FURTHER DEVIATIONS WERE NOTED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION AS MENTIONED IN THE COMPLAINT DESCRIPTION. IN SUMMARY, THERE WAS NO SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN UNKNOWN IMPLANT DURATION A DISLODGEMENT OF THIS RIGHT ATRIAL LEAD WAS REPORTED. THE LEAD WAS EXPLANTED AND REPLACED. THE IMPLANT AND EXPLANT DATES WERE NOT PROVIDED. THE LEAD WAS NOT RETURNED AT (B)(4). (B)(4) 2013 - WE WERE INFORMED THIS LEAD WAS RETURNED FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    OUS MDR - AFTER AN UNKNOWN IMPLANT DURATION A DILODGEMENT OF THIS RIGHT ATRIAL LEAD WAS REPORTED. THE LEAD WAS EXPLANTED AND REPLACED. THE IMPLANT AND EXPLANT DATES WERE NOT PROVIDED. THE LEAD WAS NOT RETURNED AT BIOTRONIK SE & CO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105543 DEXTRUS 4136 PACER LEAD NVN BIOTRONIK SE & CO. KG 360308

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization