BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILA 1CR 65 CE

    MDR report key: 5246168 · Received November 24, 2015

    Report

    Report Number
    1028232-2015-04136
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    June 8, 2015
    Report Date
    November 9, 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 UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL, MECHANICAL AND ELECTRICAL INSPECTION. THE ANALYSIS REVEALED SEVERE SIGNS OF WEAR BETWEEN 10 CM AND 15 CM PROXIMAL TO THE LEAD TIP. IN THIS AREA THE INSULATION WAS FOUND RUBBED THROUGH. THIS DAMAGE CAN BE CONSIDERED TO BE THE ROOT CAUSE FOR THE CLINICAL OBSERVATION OF NOISE. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. INTERACTION BETWEEN THE TRICUSPID VALVE AND THE LEAD SHOULD BE TAKEN INTO CONSIDERATION. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE. FURTHER ANALYSIS SHOWED SEVERAL CUTS IN THE LEAD BODY WHICH MOST LIKELY OCCURRED DUE TO MEANS OF MEDICAL INSTRUMENTS USED DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 20 MONTHS, OVERSENSING WAS OBSERVED DURING A FOLLOW UP ON (B)(6) 2015. ONE DAY LATER, OVERSENSING WAS AGAIN OBSERVED AND IN ADDITION, RV SENSING VALUES WERE REPORTED TO BE < 200 OHM. THE LEAD WAS REPLACE ON (B)(6) 2015 AND RETURNED TO BIOTRONIK FOR ANALYSIS. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778660 VIGILA 1CR 65 CE ICD LEAD NVY BIOTRONIK SE & CO. KG 382901

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization