BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA VR

    MDR report key: 3861102 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11261
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD "POSSIBLE DEVICE MIGRATION". THE DEVICE REMAINS IN USE. THE PATIENT IS ENROLLED IN THE REFINE ICD CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT COMPLAINED OF A SENSATION OF DEVICE BUZZING. A DEVICE INTERROGATION AND CHEST X-RAY WERE DONE WITH NO FINDINGS. THREE MONTHS LATER DEVICE INTERROGATION AND THE CHEST-X RAY WERE REPEATED AND IT WAS NOTED THAT THE LEFT-SIDED ICD APPEARED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339880 PROTECTA VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D334VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR 6947 LEAD