BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE 4-FRONT

    MDR report key: 14023654 · Received April 6, 2022

    Report

    Report Number
    2124215-2022-05060
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    February 4, 2022
    Report Date
    April 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PRESENTED TO THE EMERGENCY ROOM IN A HEALTH CARE FACILITY (HCF) IN (B)(6). UPON REVIEW OF THE DEVICE DATA, IT WAS NOTED THAT THE PATIENT WAS IMPLANTED WITH THE ICD SYSTEM AND WAS BEING FOLLOWED IN A HCF IN (B)(6). THE (B)(6) HCF WAS AWARE THAT THE PATIENT PRESENTED A KNOWN HISTORY OF INCREASED PACING IMPEDANCE AND THRESHOLD MEASUREMENTS FROM THIS RIGHT VENTRICULAR (RV) LEAD. IN ADDITION, THERE IS RECORD OF A HOLTER MONITOR WHERE LOSS OF CAPTURE IS DOCUMENTED. HOWEVER, WHEN THE HCF ATTEMPTED TO REACH THE PATIENT, THE PATIENT HAD ALREADY LEFT TO (B)(6). FINDINGS FROM THE HCF IN (B)(6) INDICATED THERE WAS AN INCREASED THRESHOLD AND GRADUALLY RAISING PACING IMPEDANCE MEASUREMENT, TO THE POINT OF BEING OUT OF RANGE (>2000 OHMS). IN ADDITION, A SIGNAL ARTIFACT MONITOR (SAM) EPISODE WAS NOTED ON THE RV LEAD DUE TO THESE HIGH OUT OF RANGE IMPEDANCES. INTERROGATION AND TROUBLESHOOTING PERFORMED SHOW NO INDUCIBLE NOISE AND NO SHOCK IMPEDANCE CHANGES WITH ALL MANEUVERS. ALSO, THE PATIENT WAS ADMITTED TO THE HOSPITAL, HOWEVER, IT WAS MENTIONED THAT THE ADMISSION WAS NOT RELATED TO THE DEVICE PERFORMANCE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ALSO REVIEWED THE AVAILABLE REPORTS OF THE ICD SYSTEM, NOTICING THAT THERE IS A DECREASE IN THE R WAVE AMPLITUDE AND THE ICD CURRENT MEASUREMENTS ARE QUITE DIFFERENT FROM IMPLANT, WITH EXEMPTION OF THE SHOCK IMPEDANCE. X-RAY IMAGING DOES NOT APPEAR TO SHOW ABNORMAL FINDINGS. FURTHER ADVICE AND TROUBLESHOOTING WAS PROVIDED BY TS. REPORTEDLY, THE PATIENT HAS BEEN REFERRED FOR DEVICE REVIEW IN A CLINIC IN (B)(6). AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. THE SERIAL NUMBER PROVIDED FOR THE RV LEAD IS NOT VALID, FURTHER INFORMATION WAS REQUESTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PRESENTED TO THE EMERGENCY ROOM IN A HEALTH CARE FACILITY (HCF) IN NORTHERN IRELAND. UPON REVIEW OF THE DEVICE DATA, IT WAS NOTED THAT THE PATIENT WAS IMPLANTED WITH THE ICD SYSTEM AND WAS BEING FOLLOWED IN A HCF IN PORTUGAL. THE PORTUGUESE HCF WAS AWARE THAT THE PATIENT PRESENTED A KNOWN HISTORY OF INCREASED PACING IMPEDANCE AND THRESHOLD MEASUREMENTS FROM THIS RIGHT VENTRICULAR (RV) LEAD. IN ADDITION, THERE IS RECORD OF A HOLTER MONITOR WHERE LOSS OF CAPTURE IS DOCUMENTED. HOWEVER, WHEN THE HCF ATTEMPTED TO REACH THE PATIENT, THE PATIENT HAD ALREADY LEFT TO NORTHERN IRELAND. FINDINGS FROM THE HCF IN NORTHERN IRELAND INDICATED THERE WAS AN INCREASED THRESHOLD AND GRADUALLY RAISING PACING IMPEDANCE MEASUREMENT, TO THE POINT OF BEING OUT OF RANGE (>2000 OHMS). IN ADDITION, A SIGNAL ARTIFACT MONITOR (SAM) EPISODE WAS NOTED ON THE RV LEAD DUE TO THESE HIGH OUT OF RANGE IMPEDANCES. INTERROGATION AND TROUBLESHOOTING PERFORMED SHOW NO INDUCIBLE NOISE AND NO SHOCK IMPEDANCE CHANGES WITH ALL MANEUVERS. ALSO, THE PATIENT WAS ADMITTED TO THE HOSPITAL, HOWEVER, IT WAS MENTIONED THAT THE ADMISSION WAS NOT RELATED TO THE DEVICE PERFORMANCE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ALSO REVIEWED THE AVAILABLE REPORTS OF THE ICD SYSTEM, NOTICING THAT THERE IS A DECREASE IN THE R WAVE AMPLITUDE AND THE ICD CURRENT MEASUREMENTS ARE QUITE DIFFERENT FROM IMPLANT, WITH EXEMPTION OF THE SHOCK IMPEDANCE. X-RAY IMAGING DOES NOT APPEAR TO SHOW ABNORMAL FINDINGS. FURTHER ADVICE AND TROUBLESHOOTING WAS PROVIDED BY TS. REPORTEDLY, THE PATIENT HAS BEEN REFERRED FOR DEVICE REVIEW IN A CLINIC IN NORTHERN IRELAND. THE PATIENT WAS ENROLLED IN CLOSE REMOTE MONITORING TO EVALUATE THE RV LEAD. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. THE SERIAL NUMBER PROVIDED FOR THE RV LEAD IS NOT VALID, FURTHER INFORMATION WAS REQUESTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444502 RELIANCE 4-FRONT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0682

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization