BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3160356 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10097
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. (B)(4) IMPLANTABLE DEFIB LEAD 2013 (B)(6); 5076 IMPLANTABLE PACING LEAD 2013 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SYMPTOMS OF LIGHTHEADEDNESS WITH EXERCISE. THE ELECTROCARDIOGRAM WAS CONSISTENT WITH TWAVE OVERSENSING POST PACE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO REPORTED THAT THE BI-VENTRICULAR DEFIBRILLATOR HAD A POSSIBLE LOSS OF TELEMETRY. THE RV LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE RV LEAD AND DEVICE WERE LATER EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259948 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D204TRM

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD