PERCIVA ICD DR Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Implantable Cardioverter Defibrillator (ICD) · First cleared Jul 1997
Total Reports
265
Reports (30d)
3
Active Signals
1
Open Recalls
12
What the reports describe · Claripulse analysis
Most commonly reported problems
ICD System Revision with No Effects
reported icd, infection additional, revision, icd explanted, additional adverse
3
reports
High Shock Impedance Measurements
impedance measurements, measurements, shock, impedance, range
3
reports
ICD Explanted Due to Infection
reported icd, infection additional, revision, icd explanted, additional adverse
2
reports
Pocket Infection with Erosion
infection, patient complications, pocket, icd explanted, result event
1
reports
ICD Explanted for Performance Anomaly
reported subcutaneous, effects, icd explanted, additional adverse, reported implantable
1
reports
Device Interrogation Failed
icd remains, remains service, effects, service, service adverse
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
Aug 20, 2025 · Open, Classified
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
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.
Nov 30, 2023 · Open, Classified
The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
Jul 11, 2023 · Open, Classified
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Jul 11, 2023 · Open, Classified
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Feb 2, 2023 · Open, Classified
Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..
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