BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 2121781 · Received June 13, 2011

    Report

    Report Number
    2647346-2011-00790
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THE PATIENT EXPERIENCED LEFT VENTRICULAR LEAD-RELATED DIAPHRAGMATIC PACING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT AT THE ONE MONTH VISIT, THE PATIENT COMPLAINED OF ON-GOING POST OPERATIVE LEFT CHEST NUMBNESS. NO DIAGNOSTICS OR TREATMENTS WERE ORDERED FOR THIS PATIENT AND THIS IS LISTED AS UNRESOLVED WITH NO FURTHER ACTIONS. THIS EVENT WAS CLASSIFIED AS PROCEDURE RELATED DUE TO ITS PROXIMITY TO THE IMPLANT PROCEDURE. THE DEVICE REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD