BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA MRI XT DR SURESCAN

    MDR report key: 13359687 · Received January 26, 2022

    Report

    Report Number
    3004209178-2022-01219
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    November 22, 2021
    Report Date
    January 26, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    UDI-DI
    00643169717282
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: ETUF3614C102E STENT GRAFT IMPLANTED: (B)(6) 2017; ETLW1616C124E STENT GRAFT IMPLANTED: (B)(6) 2017; OCL20US STENT GRAFT IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PHYSICIAN THOUGHT THAT THERAPY WAS INAPPROPRIATELY WITHHELD FOR TWO SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES THAT WERE SUSPECTED TO BE TRUE VENTRICULAR FIBRILLATION (VF) EPISODES WHICH RESULTED IN DELAYED THERAPY.  THE IMPLANTABLE CARDIO VERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179597 EVERA MRI XT DR SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDMB1D1 00643169717282

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Life Threatening 694765 LEAD, 407652 LEAD