BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEXTRUS 4135

    MDR report key: 2141064 · Received June 15, 2011

    Report

    Report Number
    1028232-2011-01277
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    April 22, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISLODGEMENT WITHOUT SURGICAL INTERVENTION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING 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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED INCONSISTENT P-WAVE MEASUREMENTS WITH PACING SYSTEM ANALYZER (PSA) AND NORMAL PACING IMPEDANCE VALUES. WITH THE DEVICE, PACING IMPEDANCES ARE LESS THAN 100 OHMS AND P-WAVE MEASUREMENTS ARE 0.7 MILLIVOLTS. IT WAS NOTED THEY WERE UNABLE TO TEST THRESHOLD. THE FIELD REPRESENTATIVE INDICATED THEY WATCHED THE PHYSICIAN CONNECT THE LEAD TO THE DEVICE AND NOTED NO ISSUES AND THEY DO NOT SUSPECT ANY INSULATION DAMAGE. TS RECOMMENDED PERFORMING AN X-RAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT AN X-RAY WAS PERFORMED AND THE LEAD HAD DISLODGED. THE PHYSICIAN PLANS TO CONTROL THE ISSUE WITH MEDICATION AND CARDIOVERSION. A LEAD REVISION MAY BE CONSIDERED IF NECESSARY. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED. THE DATE OF IMPLANT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4135 PACER LEAD NVZ BIOTRONIK SE & CO. KG 358744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention