ACUITY Steerable Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Mar 2008
Total Reports
227
Reports (30d)
2
Active Signals
1
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Infection at Device Pocket Site
implantable cardioverter, infection, pocket, stable condition, patient presented
1
reports
Lead Revision Due to Infection
implantable lead, effects, revision infection, reported implantable, lead revision
1
reports
Right Ventricular Lead Revision for Infection
explanted right, infection additional, revision infection, additional adverse, lead revision
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
Regulatory
FDA recalls for this device
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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