BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT DR DDBB1D4 ICD

    MDR report key: 15428320 · Received September 14, 2022

    Report

    Report Number
    MW5112060
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    September 5, 2022
    Report Date
    September 12, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE IS TONING EVERY 6 HOURS OR SO. TRANSMISSION RECEIVED AND REVIEWED. DEVICE IS TONING Q4 HOURS FOR RV LEAD IMPEDANCE WARNING. RV DEFIB IMPEDANCE NL RV BIPOLAR IMPEDANCE > 3000 RV TIP TO COIL >3000 SHORT V-V 83 VP 0.04 PERCENT PT HAS A HX OF DEFIB IN 2020 BATTERY LIFE 16 MONTHS. DR. (B)(6) ADVISED PATIENT TO GO TO EMERGENCY DEPARTMENT FOR ADMISSION DUE TO SHORT V-V'S RESULTING IN POTENTIAL INAPPROPRIATE SHOCK ON T WAVE LEADING TO VF AND POSSIBLE INADEQUATE HV THERAPY FOR DEVICE INITIATED VF DUE TO RV LEAD INTEGRITY ISSUES.  PATIENT ADVISED TO REPORT TO ED. HE WAS RELUCTANT TO GO. EXPLAINED ABOVE RATIONALE TO PT. HE AGREES TO GO TO EMERGENCY DEPARTMENT. PATIENT REPORTS THAT FOR X4 DAYS THE PATIENT HAS BEEN EXPERIENCING A "BEE STING" LIKE SENSATION (LAST OCCURRING 1 HOUR PRIOR TO EXAM). BIV ICD INTERROGATION SEVERAL EPISODES OF ATRIAL FIBRILLATION AND SVT WITH EVIDENCE OF FAR FIELD SENSING WITH RV SIGNAL ON RA LEAD. RV TIP TO RV COIL LEAD IMPEDANCE WARNING WAS PLACED ON (B)(6) 2022. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2751285 EVERA XT DR DDBB1D4 ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention PRODUCT NAME: ATRIAL LEAD PJN3252725.| PRODUCT NAME: RV LEAD TDL019060V.