Verity Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Implantable Pacemaker Pulse Generator · First cleared Aug 1989
Total Reports
233
Reports (30d)
0
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Interrogation Failure with Battery Suspected
remains service, service, stable, device remains, fysicon
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
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.
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