BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOMENTUM CRT-D

    MDR report key: 17259478 · Received July 5, 2023

    Report

    Report Number
    2124215-2023-35081
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    PMA / PMN Number
    P010012/S436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. PLEASE REFER TO B5 DESCRIBE EVENT OR PROBLEM FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS CONCERN ABOUT SHOCK IMPEDANCE VALUE FOR THIS PATIENT WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). RECENTLY THERE HAD BEEN A STEADY INCREASE IN SHOCK IMPEDANCE RANGING FROM 80 OHMS IN 2021, 103 OHMS IN 2022 AND TODAY, THE SHOCK IMPEDANCE MEASUREMENT WAS AT 124 OHMS. THIS DEVICE HAS TRIGGERED AN ALERT FOR 125 OHMS AND THE PHYSIOLOGIST HAD REPROGRAMMED AND INCREASED THE ALERT TO 150 OHMS. PDF DATA WAS REVIEWED, THE DEVICE HAS DELIVERED NO SHOCKS SINCE LAST RESET, THEREFORE NO TRUE HIGH-VOLTAGE IMPEDANCE IS AVAILABLE. THERE ARE NO OTHER ABNORMAL LEAD TRENDS OBSERVED. THE R-WAVE AMPLITUDE TREND IS SHOWING LOW VALUES POTENTIALLY MAY BE RELATED TO NOISE OVERSENSING, THEREFORE FURTHER TROUBLESHOOTING IS HIGHLY RECOMMENDED TO EXCLUDE ANY LEAD ISSUES. BOSTON SCIENTIFIC TECHNICAL SERVICES PROVIDED TROUBLESHOOTING RECOMMENDATIONS. THE PATIENT REFUSE HOME MONITORING AND SO THE PATIENT IS NOT ENROLLED IN LATITUDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN-SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS CONCERN ABOUT SHOCK IMPEDANCE VALUE FOR THIS PATIENT WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). RECENTLY THERE HAD BEEN A STEADY INCREASE IN SHOCK IMPEDANCE RANGING FROM 80 OHMS IN 2021, 103 OHMS IN 2022 AND TODAY, THE SHOCK IMPEDANCE MEASUREMENT WAS AT 124 OHMS. THIS DEVICE HAS TRIGGERED AN ALERT FOR 125 OHMS AND THE PHYSIOLOGIST HAD REPROGRAMMED AND INCREASED THE ALERT TO 150 OHMS. PDF DATA WAS REVIEWED, THE DEVICE HAS DELIVERED NO SHOCKS SINCE LAST RESET, THEREFORE NO TRUE HIGH-VOLTAGE IMPEDANCE IS AVAILABLE. THERE ARE NO OTHER ABNORMAL LEAD TRENDS OBSERVED. THE R-WAVE AMPLITUDE TREND IS SHOWING LOW VALUES POTENTIALLY MAY BE RELATED TO NOISE OVERSENSING, THEREFORE FURTHER TROUBLESHOOTING IS HIGHLY RECOMMENDED TO EXCLUDE ANY LEAD ISSUES. BOSTON SCIENTIFIC TECHNICAL SERVICES PROVIDED TROUBLESHOOTING RECOMMENDATIONS. THE PATIENT REFUSE HOME MONITORING AND SO THE PATIENT IS NOT ENROLLED IN LATITUDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888653 MOMENTUM CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G124 502470

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown