VISIONIST X4 CRT-P Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · CRT-Pacemaker (CRT-P) · First cleared Jan 2004

Total Reports

1,388

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

False Positive Battery Replacement Indicator

exhibited alert, indicator, monitoring disabled, message indicating, alert message

reports

Safety Mode Status Leading to Explantation

device explanted, subsequently, additional adverse, explanted replaced, safety mode

reports

Service Time Capacity Analysis Request

capacity request, identified potential, battery device, service time, time adverse

reports

Capacity Data Analysis Request for CRT

recommended time, time crt, identified potential, battery device, capacity data

reports

Oversensing Noise During Atrial Arrhythmia

noise, atrial, right, ventricular, lead

reports

High Impedance Battery Analysis Request

reported request, impedance battery, battery device, potential high, device recorded

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

Class I

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

Class I