Pamira S 65 Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998
Total Reports
152
Reports (30d)
15
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Explanted Due to Dislodgement
file, received file, dislodgement, file updated, updated lead
8
reports
Inappropriate Shocks from Oversensing
lead capped, inappropriate, channel, oversensing, shocks
4
reports
Lead Explanted for Under-Sensing
revision, dislodgement, leads, reported lead, explanted replaced
4
reports
Pocket Infection Leading to Explant
infection, received file, infection additional, pocket, file updated
3
reports
RV Lead Dislodgement Noted in Follow-Up
replaced patient, patient stable, dislodged, patient presented, stable
2
reports
Lead Capped Due to Oversensing
monitoring, received file, lead capped, file updated, oversensing
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
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 44,929 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 37,761 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 37,430 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 28,090 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 19,969 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,531 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
Get Early AccessUnderstanding this data