VALITUDE X4 CRT-P Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Pacemaker (CRT-P) · First cleared Jan 2004
Total Reports
2,097
Reports (30d)
86
Active Signals
1
Open Recalls
17
What the reports describe · Claripulse analysis
Most commonly reported problems
Technical Issues with Lead Placement
technical, atrial, right, ventricular, lead
53
reports
High Impedance Battery Monitoring
16
reports
High Impedance Continued Monitoring
recommended adverse, crt remains, reported crt, device recorded, reported device
12
reports
High Impedance with Device Replacement Suggested
battery condition, device replacement, battery device, capacity data, replacement recommended
12
reports
High Impedance Capacity Data Observed
observed, reported pacemaker, device replacement, pacemaker recorded, capacity data
9
reports
High Impedance Monitoring at Service Time
recommended adverse, service time, service cardiac, time cardiac, reported device
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Mar 19, 2026 · Open, Classified
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
Aug 20, 2025 · Open, Classified
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025 · Open, Classified
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025 · Open, Classified
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025 · Open, Classified
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Aug 20, 2025 · Open, Classified
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Evidence
Related research
Osada Y, et al. · Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2026
Safety of a pacemaker mode intended to protect patients
Robert G. Hauser, et al. · Heart Rhythm O2 · 2025
Daoud GE, et al. · Medical devices (Auckland, N.Z.) · 2016
Citations indexed from PubMed.
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