Acticor 7 HF-T QP DF4 IS4 ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · CRT-Defibrillator (CRT-D)
Total Reports
219
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
System Explanted Due to Infection
additional information, infection, patient stable, following, explanted
3
reports
Explanted Due to ERI with Battery Issues
battery, additional information, resolve event, patient stable, explanted
2
reports
Device Explanted Due to ERI Status
additional information, resolve event, device reprogrammed, explanted replaced, explanted
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Reiter T, et al. · Scientific reports · 2024
François C, et al. · HeartRhythm case reports · 2023
Ciriello GD, et al. · Indian pacing and electrophysiology journal · 2022
Vivarelli C, et al. · International journal of environmental research and public health · 2023
Giedrimas A, et al. · HeartRhythm case reports · 2018
Citations indexed from PubMed.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,344 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 39,133 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,062 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,710 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,671 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
Get Early AccessUnderstanding this data