BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2629845 · Received June 22, 2012

    Report

    Report Number
    1028232-2012-01603
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 2, 2012
    Report Date
    June 11, 2012
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG 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 MFG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT WITH THIS RIGHT VENTRICULAR LEAD WAS IN A CAR ACCIDENT IN (B)(6) OF 2011. SINCE THAT TIME, THERE HAS BEEN A TRENDING DECREASE IN PACING IMPEDANCE, A RISE IN THRESHOLDS AND NOISE. THE PT WAS NOT PACER DEPENDENT. BOTH THE DEVICE AND LEAD WERE REPLACED. IT IS UNK IF THE LEAD WILL BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PT EFFECTS REPORTED. AS NO FURTHER INFO CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFO BE PROVIDED. THE DATE OF EXPLANT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD NVZ BIOTRONIK, INC. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization