BEUDAMED
    FDA Adverse Event Death Summary report: N

    VEGA

    MDR report key: 17884151 · Received October 6, 2023

    Report

    Report Number
    1000165971-2023-00810
    Event Type
    Death
    Date Received
    October 6, 2023
    Date of Event
    August 16, 2023
    Report Date
    October 25, 2023
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    NVN
    PMA / PMN Number
    P130010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H1, THE TYPE OF EVENT TO BE REPORTED IN THE INITIAL REPORT, "SERIOUS INJURY" WAS SELECTED RATHER THAN 'DEATH'. THE CORRECTION WAS MADE IN THIS MDR REPORT. INVESTIGATION SUMMARY: BASED ON AVAILABLE INFORMATION, AS PERICARDIAL EFFUSION OCCURRED FOLLOWING IMPLANTATION, A VENTRICULAR CARDIAC PERFORATION COULD BE SUSPECTED. CARDIAC PERFORATION MAY BE ATTRIBUTED TO FACTORS, SUCH AS PATIENT PHYSIOLOGY OR PHYSICIAN PREFERRED IMPLANT SITE, WHICH ARE INDEPENDENT OF THE LEAD CHARACTERISTICS. IT IS A WELL-KNOWN POTENTIAL COMPLICATION ASSOCIATED TO SUCH IMPLANTABLE DEVICES, DISCUSSED IN PUBLISHED LITERATURE. DESPITE A PAINFUL IMPLANTATION PROCEDURE FOR THE PATIENT, THE LEAD WAS FINALLY CORRECTLY POSITIONED, AND ELECTRICAL PARAMETERS VALUES WERE CORRECT. THEREFORE, IN THIS CASE A LEAD MALFUNCTION IS NOT SUSPECTED. THE SUBJECT LEAD WAS STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. IT SHOULD BE NOTED THAT INFECTION IS A WELL-KNOWN COMPLICATION OF CARDIAC PACING/DEFIBRILLATION SYSTEMS, WHICH IS WELL DESCRIBED IN THE LITERATURE. NEVERTHELESS, THE INFORMATION PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AND WILL BE USED FOR TREND PURPOSES.

    Description of Event or Problem · 0

    DURING ATRIAL IMPLANTATION ON (B)(6) 2023 OF VEGA R52 IN THE RIGHT ATRIAL APPENDAGE PATIENT COMPLAINT OF SEVERE PAIN IN THE THORAX. VEGAR52 SCREW HAD BEEN TURNED 7 TIMES. ELECTRICAL MEASUREMENTS WERE SUBOPTIMAL AND LEAD WAS UNSCREWED AND REPLACED ON A DIFFERENT LOCATION WITH NORMAL THRESHOLD, SENSING AND IMPEDANCES. LITTLE EPICARDIAL FLUID WAS SEEN 5-10MM ON X-RAY. ON (B)(6) 2023, THE PATIENT WAS READMITTED TO HOSPITAL COMPLAINING OF DYSPNEA AND CHEST PAIN AND WITH PULMONARY SEPSIS. ON (B)(6) 2023, THE PATIENT DIED. ACCORDING TO THE PHYSICIAN THERE IS NO RELATION BETWEEN IMPLANT AND SEPSIS.

    Description of Event or Problem · 0

    DURING ATRIAL IMPLANTATION OF VEGA R52 IN THE RIGHT ATRIAL APPENDAGE PATIENT COMPLAINT OF ACUTE PAIN HIGH IN THE THORAX. VEGA R52 SCREW HAD BEEN TURNED 7 TIMES. ELECTRICAL MEASUREMENTS WERE SUBOPTIMAL AND LEAD WAS UNSCREWED AND REPLACED ON A DIFFERENT LOCATION WITH NORMAL THRESHOLD, SENSING AND IMPEDANCES. LITTLE EPICARDIAL FLUID WAS SEEN ON X-RAY. SOME DAYS AFTER IMPLANTATION PATIENT WAS READMITTED TO HOSPITAL WITH PULMONARY SEPSIS AND DIED A FEW DAYS LATER. ACCORDING TO THE PHYSICIAN THERE IS NO RELATION BETWEEN IMPLANT AND SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342231 VEGA DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MICROPORT CRM S.R.L. VEGA R52

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death