BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGEN EL ICD DR

    MDR report key: 11662083 · Received April 13, 2021

    Report

    Report Number
    2124215-2021-05903
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    February 11, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526534324
    PMA / PMN Number
    P960040/S306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL DUE TO SYMPTOMS OF LOW ENERGY; THE SYMPTOMS HAD PERSISTED FOR AT LEAST TWO WEEKS. THE PATIENT WAS SEEING LOW HEART RATES ON HIS HOME BLOOD PRESSURE MONITOR. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS CHECKED IN THE HOSPITAL AND FOUND TO BE FUNCTIONING NORMALLY. THE PRESENTING ELECTROGRAM REVEALED MULTIPLE PREMATURE ATRIAL CONTRACTIONS (PACS) WITH NORMAL ATRIAL AND VENTRICULAR PACING. TECHNICAL SERVICE FELT IT WAS POSSIBLE THAT THE PACS WERE CAUSING THE PACING TO BE BELOW THE LOWER RATE LIMIT (LRL) AT TIMES. FURTHER INTERROGATION DEMONSTRATED TWO BEATS BELOW THE LRL DURING A 30-MINUTE TIME PERIOD. NO REPROGRAMMING WAS PERFORMED AT THAT TIME. THE PATIENT WAS INSTRUCTED TO PERFORM A PATIENT INITIATED INTERROGATION IF SYMPTOMS REAPPEARED. THE ICD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558970 DYNAGEN EL ICD DR IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION D152 507649 00802526534324

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization