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OPTIMIZER
Impulse Dynamics (usa) Inc. · Model Smart Mini · UDI-DI 00810003380098
QFV
Prescription
0
510(k) clearances
135
Adverse events (3 deaths)
1
Recalls
3
Facilities
Description
OPTIMIZER Smart Mini Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Mini Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-05 | IMPULSE DYNAMICS (USA) INC | OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to befor |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.