BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS 4136

    MDR report key: 2942104 · Received December 27, 2012

    Report

    Report Number
    1028232-2012-03474
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    October 25, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE LEAD WAS SUBJECTED TO AN EXTENSIVE ANALYSIS, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE ANALYSIS DEMONSTRATED A RUBBED THROUGH INSULATION AT THE DISTAL PART OF THE LEAD. THIS DAMAGE CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE OBSERVED OVERSENSING ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTIC OF THIS DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SERVE MECHANICAL STRESS IN THE IMPLANTED STATE. THE INTERACTION WITH THE TRICUSPID VALVE SHOULD BE TAKEN INTO CONSIDERATION. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGES 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 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

    ADDITIONAL INFORMATION WAS RECEIVED THREE MONTHS AFTER THE INITIAL OBSERVATIONS NOTING THAT INTERMITTENT LOSS OF CAPTURE WAS STILL BEING OBSERVED AND THE PATIENT WAS SYMPTOMATIC. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO ADDRESS THE ISSUES. A REVISION PROCEDURE WAS PERFORMED AND THE ASSOCIATED RIGHT VENTRICULAR LEAD WAS REPLACED AND THE DEVICE WAS EXPLANTED AND THE PATIENT RECEIVED A NEW RV LEAD AND AN UPGRADED DEVICE AS HE HAD DEVELOPED CONGESTIVE HEART FAILURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS IN THE EMERGENCY ROOM DUE TO LIGHTHEADEDNESS WITH SOME INTERMITTENT LOSS OF CAPTURE. UPON INTERROGATION THERE WAS SOME LOC NOTED WITH OVERSENSING AND NOISE ON THIS RIGHT VENTRICULAR LEAD WHICH RESULTED IN PACING PAUSES. THE PATIENT IS SYMPTOMATIC DURING THE PAUSES. THE ASSOCIATED DEVICE IS PROGRAMMED TO MAXIMUM OUTPUTS AND THE RV SENSITIVITY IS PROGRAMMED TO LEST SENSITIVE. HOWEVER, THE PAUSES ARE STILL OCCURRING. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED PROGRAMMING OPTIONS FOR THIS PATIENT. THE CALLER PERFORMED REPROGRAMMING AND REPORTED SEEING MORE REGULARIZATION FO THE V-V INTERVALS. BIPOLAR IMPEDANCE MEASUREMENT IS 460 OHMS AND THE TREND APPEARS TO BE STABLE FOR THIS LEAD. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization