Victory Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Implantable Pacemaker Pulse Generator · First cleared Aug 1989
Total Reports
238
Reports (30d)
1
Active Signals
0
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
High Capture Threshold with Device in Service
replaced, remains service, lead exhibited, service, device remains
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Jun 17, 2022 · Open, Classified
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Jun 17, 2022 · Open, Classified
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
Jun 17, 2022 · Open, Classified
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,089 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 38,723 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 38,006 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,057 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,299 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,625 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.
Get Early AccessUnderstanding this data