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ADVANCED NEUROMODULATION SYSTEMS, INC. · Model MN13650 · UDI-DI 05415067053060

PMP Prescription

510(k) clearances

19,915

Adverse events (32 deaths)

Recalls

Facilities

Description

DRG Big Curve Delivery Sheath Kit

Recalls

Date	Firm	Reason
2024-05-16	Abbott Medical	The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
2018-03-09	St. Jude Medical, Inc.	The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient

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Data 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.