VALITUDE X4 CRT-P Adverse Events: FDA MAUDE Data

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

Total Reports

1,805

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

Voltage Low Code with Replacement Recommendation

projected remaining, recorded code, voltage low, low projected, remaining capacity

reports

High Impedance Battery Analysis Request

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

reports

Safety Mode Status Leading to Explantation

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

reports

Voltage Alert Triggered by Battery Condition

identified voltage, voltage alert, condition device, battery condition, alert triggered

reports

Battery Capacity Data Analysis Request

capacity reported, reported request, battery device, analyzed data, 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