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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 ManagementVOLTA

VOLTA Adverse Events: FDA MAUDE Data

BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998

Total Reports

126

Reports (30d)

3

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 from Oversensing

additional information, received file, file updated, inappropriate, shocks

3

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

Prevalence and predictors of diabetes distress in Volta Region, Ghana: a health facility-based cross-sectional study.

Attidigah REG, et al. · 2026

Dialogue through film: engaging midwives, TBAs, and mothers to improve maternal health outcomes in Ghana's Volta region.

Koppitz S, et al. · 2025

Prevalence and predictors of virological failure and quality of life of people with HIV/AIDS at a Municipal Hospital, Volta Region -Ghana: A cross-sectional study.

Peprah KG, et al. · 2026

Spatial analysis of under-five children mortality and associated determinants in Ghana: Mapping regional disparities for targeted interventions.

Iddrisu AK, et al. · 2026

Adolescent pregnancy estimates, spatial distribution, and policy implications in the Volta Region, Ghana, 2019-2023.

Kubio C, et al. · 2026

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.