BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 2131939 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03515
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 29, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT, WHEN THE DOCTOR WAS REPOSITIONING THE RIGHT ATRIUM LEAD, THE GROMMET WAS POPPED OUT AND WAS NOT BE ABLE TO USE. DOCTOR COVERED THE SET SCREW WITH MEDICAL ADHESIVE/SILICONE TO PREVENT ANY CURRENT LEAKAGE. THE LEAD WAS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 1346T COMPETITOR IMPLANTABLE PACING LEAD