PNS Freedom-8A Permanent Neurostimulator Receiver Kit Channel B FR8A-RCV-B0Recalls & reported problems
Curonix LLC · PNS Freedom-8A Permanent Neurostimulator Receiver Kit Channel B · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850051034314), received between Nov 4, 2024 and Aug 12, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
6 other recalls cover devices cleared under the same FDA submission (K152178); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Bruise/Contusion1
- Burning Sensation1
- Impaired Healing1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2025Use of Device Problem; Use of Device Problem
THE PATIENT REPORTED IMPAIRED HEALING AT THE INCISION SITE. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025.
Patient problems: Impaired Healing
MAUDE report 22789943 ↗InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED GRADUAL LOSS OF THERAPY AS WELL AS A TINGLING/BURNING SENSATION AT THE ANTENNA SITE WHEN USING THE DEVICE. ADDITIONALLY, THERE WAS DISCOLORATION SIMILAR TO A BRUISE IN THE AREA OF THE ANTENNA WHICH DISAPPEARED WHEN THE PATIENT STOPPED USING THE DEVICE. ATTEMPTS WERE MADE TO CHANGE THE TRANSMITTER SETTINGS WITHOUT SUCCESS AND A REPLACEMENT PROCEDURE IS SCHEDULED. HOWEVER, A DATE WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Bruise/Contusion; Burning Sensation
MAUDE report 20604144 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152178. One submission often covers many models, so check the product and lot details in each record.
- Z-2930-2020 · Jul 15, 2020 · Open, ClassifiedStimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief
- Z-2928-2020 · Jul 15, 2020 · Open, ClassifiedStimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relie
- Z-2932-2020 · Jul 15, 2020 · Open, ClassifiedStimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractabl
- Z-2929-2020 · Jul 15, 2020 · Open, ClassifiedStimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractabl
- Z-2933-2020 · Jul 15, 2020 · Open, ClassifiedStimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic re
- Z-2931-2020 · Jul 15, 2020 · Open, ClassifiedStimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractab
Other Stimulator, Peripheral Nerve, Implanted (Pain Relief) devices
- Quattrode™ 3166St. Jude Medical, Inc. · STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)429 reports
- Quattrode™ 3169St. Jude Medical, Inc. · STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)401 reports
- PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A STQ4-RCV-A0Curonix LLC · Stimulator, Peripheral Nerve, Implanted (Pain Relief)8 deaths364 reports
- Nalu Medical, Inc. 71019-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall225 reports
- StimQ Receiver Stimulator Kit Channel A US w/Receiver STQ4-RCV-A0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)3 deaths270 reports
- Nalu Medical, Inc. 71020-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)213 reports
- StimQ Spare Lead Kit Channel B US w/Receiver STQ4-SPR-B0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)126 reports
- Nalu Medical, Inc. 71005-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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