ABBOTT PACEMAKER Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Implantable Pacemaker Pulse Generator · First cleared Sep 2017
Total Reports
103
Reports (30d)
2
Active Signals
0
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead Noise with Generator Failure
remains service, pulse generator, service, ipg, remains
6
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.
Evidence
Related research
Increased incidence of electrical abnormalities in a pacemaker lead family
EVAN C. ADELSTEIN, et al. · Journal of Cardiovascular Electrophysiology · 2021
Performance of automatic capture confirmation algorithm in a large cohort of pacemaker patients with left bundle branch area pacing.
Bernabei MA, et al. · Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
Citations indexed from PubMed.
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