BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIGILA 1CR 65 CE

    MDR report key: 2974097 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00225
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 29, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    SORIN REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD SCREW MECHANISM WAS DEPLOYED SUCCESSFULLY BUT LEAD DISPLACED SEVERAL TIMES. AT END OF THE PROCEDURE, THE LEAD APPEARED TO BE IN GOOD POSITION WITH GOOD ELECTRICAL MEASUREMENTS BOTH THROUGH THE PSA AND DEVICE. AT THE PRE-DISCHARGE X-RAY, THE LEAD HAD OBVIOUSLY DISPLACED AGAIN. REPOSITIONING WAS ATTEMPTED BUT THE LEAD WOULD NOT STAY IN PLACE EVEN THOUGH THE SCREW MECHANISM FUNCTIONED CORRECTLY. THE LEAD WAS REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64413 VIGILA 1CR 65 CE ICD LEAD NVY BIOTRONIK SE & CO. KG 382901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization