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Freedom Spinal Cord Stimulator System
STIMWAVE TECHNOLOGIES INCORPORATED · Model FR4A-TRL-A0 · UDI-DI 00859619004097
GZB
Prescription
1
510(k) clearances
43,932
Adverse events (196 deaths)
5
Recalls
34
Facilities
Description
Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel A US
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-07-29 | St. Jude Medical, Inc. | The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to |
| 2014-07-29 | St. Jude Medical, Inc. | The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to |
| 2010-02-22 | Advanced Neuromodulation Systems, Inc | Directions For Use of product incorrectly stated lead compatibility information. |
| 2008-05-21 | Medtronic Neuromodulation | Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm i |
| 2005-11-22 | Medtronic Inc, Neurological & Spinal Division | A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80 |
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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.