BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAGEN MINI ICD DR

    MDR report key: 12113694 · Received July 3, 2021

    Report

    Report Number
    2124215-2021-14998
    Event Type
    Malfunction
    Date Received
    July 3, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526533907
    PMA / PMN Number
    P960040/S306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. INVESTIGATION HAS DETERMINED THAT THIS TYPE OF EVENT IS LIKELY THE RESULT OF AN INTERMITTENT HIGH IMPEDANCE CONDITION ASSOCIATED WITH THE DEVICE SPRING CONTACT AND LEAD TERMINAL RING. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2020 TO STABILIZE THE ELECTRICAL CONNECTION BETWEEN THE SPRING CONTACT AND THE LEAD TERMINAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES. IT WAS NOTED IMPEDANCES INCREASED FROM 700-2236 OHMS HOWEVER, THERE WERE NO STORED EPISODES. THE ICD AND NON-BOSTON SCIENTIFIC RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES. IT WAS NOTED IMPEDANCES INCREASED FROM 700-2236 OHMS HOWEVER, THERE WERE NO STORED EPISODES. THE ICD AND NON-BOSTON SCIENTIFIC RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010487 DYNAGEN MINI ICD DR IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION D022 118894 00802526533907

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR