BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT VR

    MDR report key: 6006855 · Received October 6, 2016

    Report

    Report Number
    3004209178-2016-20842
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 8, 2016
    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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. CONCOMITANT MEDICAL DEVICES: 693265 LEAD , IMPLANT DATE : (B)(6) 2000.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTITACHYCARDIA PACING THERAPY (ATP) WHEN THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LABELED MULTIPLE SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES AS VENTRICULAR TACHYCARDIA (VT). THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657685 EVERA XT VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO DVBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| L| R 507645 LEAD