BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY GEN MODEL 8103

    MDR report key: 11059794 · Received December 22, 2020

    Report

    Report Number
    1644487-2020-01721
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    December 9, 2020
    Report Date
    November 4, 2021
    Product Code
    MUZ
    UDI-DI
    05425025750504
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT OR PROBLEM: NO HEART RATE CHANGE AT 0.25MA REPORTED WAS INCORRECTLY INCLUDED IN INITAL MDR.

    Additional Manufacturer Narrative · 0

    A2. AGE AT TIME OF EVENT - CORRECTION - PATIENT AGE WAS INCORRECTLY REPORTED IN INITIAL MDR. F10. ADVERSE EVENT PROBLEM, HEALTH EFFECT - CLINICAL CODE - CORRECTION - CODE E060104 FOR "BRADYCARDIA" WAS NOT INCLUDED IN SUPPLEMENTAL #1 MDR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ASYSTOLE OCCUR WITH SYSTEM DIAGNOSTICS AT 0.25MA. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    THE BRADYCARDIA AND ASYSTOLE WERE REPORTED TO BE CASUAL TO THE IMPLANT SURGERY AS WELL AS DEVICE STIMULATION. THE PATIENT DISCONTINUED THE CLINICAL TRIAL. THE PATIENT HAD A FULL SYSTEM EXPLANT PERFORMED. THE EXPLANTED DEVICES WERE NOTED TO BE NOT AVAILABLE FOR RETURN. THE EXPLANTED DEVICES HAVE NOT BEEN RECEIVED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BARDYCARDIA WAS OBSERVED AT 1.0MA AND 1.5MA. NO ARRHYTHMIA WAS OBSERVED AT 0.25MA. THE RELATIONSHIP WAS REPORTED TO BE CAUSAL DUE TO VNS STIMULATION. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SENT INTO ASYSTOLE DURING IMPLANT SURGERY. WHEN SYSTEM DIAGNOSTICS WERE PERFORMED, THE PATIENT HEART RATE DROPPED TO ASYSTOLE. ANESTHETIST ADMINISTERED ATROPINE AND THE PATIENT HEART RATE WENT BACK TO NORMAL. SYSTEM DIAGNOSTICS WERE PERFORMED AGAIN AND PATIENT WENT INTO ASYSTOLE AGAIN. STIMULATION WAS ATTEMPTED AT 0.25MA AND NO HEART RATE CHANGE WAS OBSERVED. IT WAS NOTED THAT THE PATIENT HAD A KNOWN BRADYCARDIA AND HAD NO SUPPORT FROM A CARDIOLOGIST RIGHT NOW. IT WAS STATED THAT THE BRADYCARDIA WOULD HAVE TO GET SOLVED BY MEDICATION OR A PACEMAKER. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524831 SYMMETRY GEN MODEL 8103 GENERATOR MUZ 8103 205106 05425025750504

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R