Intica Neo 5 VR-T DX DF-1 ProMRI Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Implantable Cardioverter Defibrillator (ICD) · First cleared May 2024
Total Reports
109
Reports (30d)
4
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Elective Replacement Indicator with Device Replacement
battery, device explanted
4
reports
Elective Replacement Indicator Prompting Explant
device explanted, icd explanted, showed
3
reports
Intrinsic Signal Drop Causing Noise Oversensing
shock, effects remains, sensing vector, vector, patient inappropriate
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
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