BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILA 2CR 60/16

    MDR report key: 2942006 · Received December 21, 2012

    Report

    Report Number
    1028232-2012-03326
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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

    (B)(6) SALES REPRESENTATIVE REPORTED THAT THIS LEAD WAS EXPLANTED BECAUSE IT WAS CAUSING INAPPROPRIATE SHOCKS DUE TO NOISE. A NEW SORIN LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGILA 2CR 60/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 382924

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization