BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 3905208 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12325
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A VENTRICULAR FIBRILLATION (VF) EPISODE. HIGH VOLTAGE THERAPY WAS PROVIDED MULTIPLE TIMES BUT WAS UNABLE TO BREAK THE RHYTHM. THE VF RHYTHM CONVERTED SPONTANEOUSLY. THE PATIENT IS NOTED TO HAVE LOST CONSCIOUSNESS, FELL AND CHIPPED TEETH DURING EPISODE. THE DEVICE AND LEAD REMAIN IN USE. THE LEAD WILL BE REPOSITIONED AND DEFIBRILLATION THRESHOLD TESTING WILL BE COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382508 PROTECTA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314VRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Hospitalization| R 6947-58 LEAD