BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-P

    MDR report key: 2811899 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02353
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    June 4, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P010015/S084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THERE WAS NO DATA AVAILABLE FROM THE IMPLANTABLE PULSE GENERATOR (IPG). THE DEVICE WAS IMPLANTED WITHOUT AND ATRIAL LEAD SO THE "IMPLANT DETECT" FROM THE RECENT IMPLANT DID NOT COMPLETE. THE DEVICE WAS REPROGRAMMED TO "IMPLANT DETECT" OFF AND IS 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 CONSULTA CRT-P IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. C4TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD