EMBLEM S ICD Adverse Events: FDA MAUDE Data
Oscor Inc. · Implantable Cardioverter Defibrillator (ICD) · First cleared Oct 2021
Total Reports
1,067
Reports (30d)
9
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Intrinsic Signal Drop Causing Noise Oversensing
shock, effects remains, sensing vector, vector, patient inappropriate
3
reports
Subcutaneous System Explant for Unspecified Cause
implantable cardioverter, subcutaneous, subcutaneous implantable, cardioverter defibrillator, electrode
2
reports
Post-MRI Backup Mode Disables High-Voltage Therapy
event patient, high voltage, therapy, contacted, technical
1
reports
Electrode Fracture Requiring Replacement
adverse, revision, effects, electrode, additional adverse
1
reports
Subcutaneous Noise Oversensing Causes Repeated Shocks
noise, reported subcutaneous, subcutaneous implantable, effects, service
1
reports
Subcutaneous Noise Oversensing with Disabled Therapy
subcutaneous implantable, sensing, services, sensing vector, vector
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Keep exploring
Related devices in CRM
CAPSUREFIX NOVUS
MEDTRONIC, INC. · 65,814 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 38,988 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 38,556 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,627 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,717 reports
LINQ II
MEDTRONIC, INC. · 10,358 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.
Get Early AccessUnderstanding this data