BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILA 1CR 65 CE

    MDR report key: 4871233 · Received June 26, 2015

    Report

    Report Number
    1028232-2015-02215
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    July 27, 2012
    Report Date
    June 15, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    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 FOUND CUT SOME 8 CM DISTAL TO THE DF-1 CONNECTOR PIN. ONLY THE PROXIMAL FRAGMENT OF THE DF-1 CONNECTOR WAS RECEIVED FOR ANALYSIS. THE DISTAL PART OF THE LEAD INCLUDING THE IS-1 CONNECTOR, THE YOKE, THE SHOCK-COILS AND THE LEAD TIP WERE NOT RETURNED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS CUT IN THE COURSE OF THE EXPLANTATION PROCEDURE. DUE TO THE CUT THE MECHANICAL OF THE LEAD WAS NOT PROPERLY FEASIBLE. THE ELECTRICAL INSPECTION OF THE LEAD WAS LIMITED TO THE DC RESISTANCES OF THE RETURNED CONNECTOR FRAGMENT. NO PECULIARITIES WERE FOUND. WITH REGARD TO THE ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS OF THE AVAILABLE LEAD FRAGMENT DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE ANALYSIS OF THE RETURNED FRAGMENT DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Additional Manufacturer Narrative · 1

    THE LEAD IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE LEAD IMPEDANCE VALUES WERE HIGHER THAN 3000 OHM. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ARRHYTHMIAS NOT TREATED BY THE IMPLANTED TACHY SYSTEM. DURING THE FOLLOW-UP THERE WERE SEVERAL WARNING MESSAGES DISPLAYED ON THE PROGRAMMER. NO FURTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE IMPLANT AND EXPLANT DATES ARE NOT AVAILABLE. THE LEAD WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416223 VIGILA 1CR 65 CE ICD LEAD NVY BIOTRONIK SE & CO. KG 382901

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization