Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
Recall
- Recall Number
- Z-2257-2024
- Event Number
- 94682
- Firm
- Nalu Medical, Inc.
- FEI Number
- 3015425075
- Product Code
- GZF
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 3, 2024
- Posted
- July 3, 2024
- Address
- 2320 Faraday Ave, Ste 100, Carlsbad, CA, 92008-7216
Description
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
On 6/3/24, recall notices were mailed and emailed to Physicians managing patients with Implanted Pulse Generators (IPG) who were informed of the following: 1) Four of the IPGs have been found to have low RF efficiency readings. 2) Firm recommends monitoring the patients with IPGs with low RF efficiency readings through healthcare visits that occur to ensure proper functioning of the Neurostimulation Kit/Peripheral Nerve Stimulation Kit and working with your field representative to address any issues in the event the device is not performing as intended since there are other factors that could cause similar product behaviors. If troubleshooting is unable to restore functionality, it is recommended that you make a clinical assessment around replacement surgery. Ultimately, the decision to act and/or communication with the patient will be at your discretion. 3) If you find a device that has been identified as part of the recalled product to be nonfunctional, you should notify us immediately through your local sales representative, our technical support line at (800) 618-3402 4) Complete and return the response form via email to [email protected] 5) If you have any questions, please call your local sales representative at (480) 313-9745.
US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
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