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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Cardiac Rhythm Management
MAUDE LookupCardiac Rhythm ManagementPLATINIUM

PLATINIUM Adverse Events: FDA MAUDE Data

MICROPORT CRM SRL · CRT-Defibrillator (CRT-D) · First cleared May 2008

Total Reports

244

Reports (30d)

1

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Inappropriate Shock Delivered by ICD

implantable cardioverter, icd, intervention, cardioverter defibrillator, defibrillator icd

1

reports

2

Inappropriate Therapy for Atrial Fibrillation

crt, atrial, effects, therapy, service

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

Disproportionate reportingmedium

Evidence

Related research

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Hernandez Padilla AC, et al. · 2026

Daily practices in chemotherapy for advanced gastric or gastroesophageal junction adenocarcinoma: METESTOMAC French prospective cohort.

Manfredi S, et al. · 2022

Immune checkpoint inhibitors as potential therapy for reverting T-cell exhaustion and reverting HIV latency in people living with HIV.

Benito JM, et al. · 2023

Triple-negative breast cancer treatment with core-shell Magnetic@Platinium-Metal organic framework/epirubicin nano-platforms for chemo-photodynamic based combinational therapy: A review.

Xu K, et al. · 2024

Monocyte HLA-DR expression in septic shock patients: insights from a 20-year real-world cohort of 1023 cases.

Monneret G, et al. · 2025

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.