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StimQ Receiver Stimulator Kit Channel A US w/Receiver STQ4-RCV-A0Recalls & reported problems

Stimwave Technologies Incorporated · StimQ Peripheral Nerve Stimulator System StimQ Receiver Stimulator Kit Channel A US w/Receiver · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Stimwave StimQ peripheral nerve stimulator for pain relief has 269 reports, including 3 deaths and 266 injuries. Many describe pain, skin erosion, and infection near the implanted receiver, and some describe the device migrating or pushing through the skin. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
270
Deaths reported
3
Injuries reported
267
Recalls naming it
0

Summary

The FDA's MAUDE database contains 270 adverse event reports that list this exact device (DI 00818225020464), received between Nov 30, 2018 and Sep 15, 2026 — classified as 3 deaths, 267 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (23 reports).

6 other recalls cover devices cleared under the same FDA submission (K171366); 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

Nov 2023: 7 reportsDec 2023: 3 reportsJan 2024: 3 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 3 reportsMay 2024: 3 reportsJun 2024: 2 reportsJul 2024: 2 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 2 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 2 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 3 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem190
  • Migration or Expulsion of Device23
  • Use of Device Problem14
  • Migration12
  • Material Erosion10
  • Appropriate Device Problem Term/Code Not Available7
  • Material Protrusion/Extrusion7
  • Inappropriate/Inadequate Shock/Stimulation3

Patient problems

  • Pain56
  • Erosion53
  • Skin Infection38
  • Impaired Healing29
  • Skin Inflammation/ Irritation28
  • Post Operative Wound Infection27
  • Unspecified Infection17
  • Swelling/ Edema16

Recent adverse event reports

The 25 most recent of 270 reports, in the reporter's own words as published by the FDA.

  • InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

    Patient problems: Erosion

    MAUDE report 50781614 ↗
  • InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

    CURONIX SUPPORT RECEIVED A CALL FROM AN MRI FACILITY INFORMING CURONIX THE PATIENT HAD THEIR DEVICE EXPLANTED ON (B)(6) 2023. ON (B)(6) 2026, THE COMMERCIAL TEAM MEMBER WAS ABLE TO SPEAK WITH THE IMPLANTING CLINICIAN AND REPORTED THE PATIENT HAD AN INFECTION AT THE RECEIVER SITE. THE PATIENT WAS IN THE EMERGENCY ROOM FOR 30 HOURS. HOWEVER, THEY WERE NEVER ACTUALLY SEEN AND LEFT AGAINST MEDICAL ADVICE. THE PATIENT TRAVELED BACK TO (B)(6) AND MET WITH THE IMPLANTING CLINICIAN WHERE AN EXPLANT PROCEDURE WAS SCHEDULED AND PERFORMED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Skin Infection

    MAUDE report 25321311 ↗
  • InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTED PAIN AND DISCOMFORT WITH VARIOUS ARM MOVEMENTS NEAR THEIR NEUROSTIMULATOR. THE PATIENT STATED THE STIMULATION DOES NOT SEEM TO BE THE ISSUE AS THEY WERE GETTING GOOD RELIEF OVERALL. HOWEVER, THE SUTURES AND SCAR TISSUE AROUND THE NEUROSTIMULATOR SEEM TO BE CAUSING IRRITATION. THE PATIENT HAS A FOLLOW UP APPOINTMENT ON (B)(6) 2026 TO DISCUSS PLANS GOING FORWARD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: Discomfort

    MAUDE report 25207004 ↗
  • InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

    CURONIX RECEIVED A CALL FROM THE MRI DEPARTMENT AT (B)(6) HOSPITAL REGARDING A PATIENT WHO HAD BROKEN NEUROSTIMULATORS. THE PATIENT NOTED THEIR DEVICES BROKE WHILE MOVING AND LIFTING HEAVY BOXES. CURONIX ADVISED AGAINST AN MRI AND RECOMMENDED AN X-RAY INSTEAD. CLARIFICATION WAS RECEIVED ON APRIL 30, 2026. THE PATIENT'S CLINICIAN WAS NOT FAMILIAR WITH THE CURONIX DEVICES AND BELIEVED THE DEVICES WERE BROKEN. HOWEVER, AN X-RAY WAS NOT PERFORMED TO CONFIRM THE ALLEGED DEFICIENCY. THE PATIENT HAS NOT WORN THEIR CURONIX DEVICE IN YEARS. HOWEVER, THEY WOULD LIKE TO RESUME THERAPY AFTER THEY ARE ABLE TO OBTAIN AN MRI OF THEIR KNEE. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE PATIENT TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25166884 ↗
  • InjuryMar 12, 2026Use of Device Problem

    THE PATIENT REPORTED EROSION. ADDITIONALLY, THE RECEIVER SITE "NEVER QUITE HEALED" AND THEY COULD ALWAYS FEEL A BUMP UNDERNEATH THE SKIN. ANTIBIOTICS WERE PRESCRIBED PROPHYLACTICALLY AND AN EXPLANT PROCEDURE WAS SCHEDULED FOR (B)(6) 2026. DURING THE EXPLANT PROCEDURE, THE NEUROSTIMULATOR BROKE AT THE CIRCUITRY AND TINES. THE ELECTRODES WERE LEFT IN PLACE AT THE TIBIAL FLARE AND THE PATIENT HAS AN APPOINTMENT ON (B)(6) 2026 WITH THE ORTHOPEDIC SURGEON TO DISCUSS WHETHER OR NOT THE REMAINDER OF THE NEUROSTIMULATOR WILL BE REMOVED. AS OF (B)(6) 2026, THE PATIENT'S WOUND IS OTHERWISE HEALING WELL, WITH NO SURROUNDING REDNESS OR DRAINAGE. THE COMMERCIAL TEAM MEMBER HAS MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT REGARDING THEIR APPOINTMENT WITH THE ORTHOPEDIC SURGEON. HOWEVER, THE ATTEMPTS HAVE BEEN UNSUCCESSFUL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: Erosion; Impaired Healing

    MAUDE report 24583549 ↗
  • InjuryDec 15, 2025Migration; Migration

    THE PATIENT REPORTED THEY STOPPED USING THEIR DEVICE DUE TO INCREASED PAIN IN THEIR ANKLE. MIGRATION WAS CONFIRMED VIA X-RAY WHICH REVEALED THE NEUROSTIMULATOR MIGRATED OVER THE JOINT LINE. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Patient problems: Pain

    MAUDE report 23809958 ↗
  • InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTED THE NEUROSTIMULATOR WAS POPPING UP AT ONE OF THE INCISION SITES. ADDITIONALLY, THE PATIENT REPORTED THE SYSTEM NEVER REALLY WORKED WELL FOR THEM AFTER THE PERMANENT IMPLANT PROCEDURE. THERE ARE NO PLANS FOR AN EXPLANT OR REVISION PROCEDURE AND THE PATIENT WAS ENCOURAGED TO CALL THE OFFICE TO SET UP A TIME TO COME IN TO FURTHER INVESTIGATE THE ISSUE. AS OF NOVEMBER 11, 2025, THE PATIENT HAS NOT CALLED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: Erosion

    MAUDE report 23512585 ↗
  • InjurySep 11, 2025Use of Device Problem; Use of Device Problem

    THE PATIENT REPORTEDLY EXPERIENCED A SHOCK IN THE IMPLANT REGION WHILE GETTING A MASSAGE. X-RAYS WERE PERFORMED WHICH RULED OUT MIGRATION. AS OF (B)(6) 2025, THE PATIENT HAS NOT EXPERIENCED ANY ADDITIONAL SHOCKS, THE PATIENT IS DOING BETTER AND CONTINUES TO USE THE DEVICE AS THEY WERE PRIOR TO THE SHOCK. IT IS UNKNOWN WHICH NEUROSTIMULATOR EMITTED THE SHOCK. THEREFORE, BOTH DEVICES WERE INCLUDED IN THE INVESTIGATION.

    Patient problems: Shock from Patient Lead(s)

    MAUDE report 23027950 ↗
  • InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

    THE PATIENT REPORTED A SUPERFICIAL INFECTION NEAR THE INCISION SITE. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6)) 2025. THE PATIENT HAS NOT DECIDED ON NEXT STEPS. THE COMMERCIAL TEAM MEMBER WILL REMAIN IN CONTACT WITH THE PHYSICIAN AND PATIENT AND WILL PROVIDE ADDITIONAL INFORMATION IF IT BECOMES AVAILABLE.

    Patient problems: Skin Infection

    MAUDE report 22023365 ↗
  • InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2025, SUPPORT RECEIVED A CALL REQUESTING MRI CLEARANCE FOR A PATIENT WHO WAS IN THE HOSPITAL FOR LOWER BACK PAIN. THE PATIENT MET MRI CRITERIA, THEY WERE AWAKE, AND ABLE TO COMMUNICATE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025. THE PATIENT STATED THEY WERE HOSPITALIZED DUE TO PAIN FROM THEIR CHEMOTHERAPY TREATMENT FOR LEUKEMIA WHICH ENHANCES THEIR SPINAL STENOSIS PAIN, SPECIFICALLY ON THEIR RIGHT SIDE. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL, WILL FOLLOW-UP WITH THEIR PRIMARY CARE PHYSICIAN, AND HAS NO CONCERNS OVER THE CURONIX DEVICE.

    Patient problems: Pain

    MAUDE report 21577157 ↗
  • InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS IMPLANTED WITH A NEUROSTIMULATOR (B)(6) 2021 AND AT THE TIME OF THE IMPLANT, THE PATIENT INDICATED THEY WORKED AROUND MRI MACHINES. THE PATIENT REPORTEDLY EXPERIENCED SHOCKS/TINGLING IN OTHER PARTS OF THEIR BODY WHEN WORKING AROUND THE MRI AREA EVEN WITHOUT WEARING THE DEVICE. THE PATIENT STOPPED WEARING THE DEVICE YEARS AGO AND STAYED AWAY FROM MRI LOCATIONS AT WORK. THE PATIENT IS REPORTING THE SHOCKS/TINGLING AS THEY WILL NEED TO BE NEAR MRI FACILITIES AND ARE NOT COMFORTABLE IN DOING SO BECAUSE OF THE TINGLING THEY FELT. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE PATIENT TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Patient problems: Electric Shock

    MAUDE report 21542851 ↗
  • InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2025 THE PATIENT EXPERIENCED A STROKE WHICH WAS CONFIRMED VIA MRI. THE PATIENT IS EXPERIENCING WEAKNESS ON THEIR RIGHT SIDE AS WELL AS SOME SPEECH ISSUES. AS OF (B)(6) 2025, THE PATIENT IS IN REHAB AND GETTING STRONGER.

    Patient problems: Stroke/CVA

    MAUDE report 21370698 ↗
  • InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTED IMPAIRED WOUND HEALING AND EROSION. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED IN (B)(6) 2024. HOWEVER, AN EXACT DATE IS UNKNOWN. THE PATIENT WAS IMPLANTED WITH TWO NEW NEUROSTIMULATORS ON (B)(6) 2024 AND THE PATIENT IS DOING WELL.

    Patient problems: Erosion; Impaired Healing

    MAUDE report 21106149 ↗
  • InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTED THEIR LEGS AND KNEES ARE FALLING ASLEEP AN HOUR AFTER WEARING THEIR DEVICE. THE PATIENT WAS INSTRUCTED TO STOP WEARING THE DEVICE WHICH RESOLVED THE NUMBNESS. THE PATIENT RESUMED THERAPY ON (B)(6) 2024 AND REPORTED THERAPY IS WORKING WELL NOW AND THEY DO NOT HAVE ANY PAIN.

    Patient problems: Numbness

    MAUDE report 21087884 ↗
  • InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTEDLY FELT A SLIGHT VIBRATION ON THEIR LEFT SIDE, LIKE STIMULATION ON THEIR NEUROSTIMULATOR WAS ON, DURING AN MRI. THE PATIENT DID NOT REPORT DISCOMFORT OR PAIN. THE MRI WAS ABORTED. THE PATIENT IS DOING WELL AND HAS NOT RECEIVED ANY UNCOMFORTABLE STIMULATION OR IRRITATION SINCE INSIDE THE MRI MACHINE. THEY ARE VERY HAPPY ABOUT HAVING THE CURONIX STIMULATOR WITH ADEQUATE PAIN RELIEF.

    Patient problems: Shock from Patient Lead(s)

    MAUDE report 20827842 ↗
  • InjuryNov 13, 2024Migration; Migration

    THE PATIENT REPORTED AN INCREASE IN BUTTOCK PAIN. MIGRATION WAS CONFIRMED VIA X-RAY AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2024, AND NEW NEUROSTIMULATOR WAS IMPLANTED. THE PATIENT IS DOING WELL AND NO FURTHER ISSUES HAVE BEEN REPORTED.

    Patient problems: Pain

    MAUDE report 20678717 ↗
  • InjuryOct 17, 2024Off-Label Use; Off-Label Use

    THE PATIENT REPORTED PAIN BEHIND THE EYES, FOREHEAD, EARS, BASE OF THE SKULL, AND NECK AS WELL AS TUNNEL HEARING AND WORSENING VERTIGO. ADDITIONALLY, THE PATIENT REPORTED PRESSURE LIKE ITS GOING TO POP. THE PATIENT ALSO REPORTED INADEQUATE PAIN RELIEF FROM THE DEVICE SINCE IT WAS IMPLANTED AND THEY HAVE NOT WORN THEIR DEVICE SINCE 2022. AN EXPLANT PROCEDURE WILL BE PERFORMED. HOWEVER, A DATE HAS NOT BEEN SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Patient problems: Hearing Impairment; Pain; Vertigo

    MAUDE report 20477137 ↗
  • InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTED SEVERAL INFECTIONS AT THE RECEIVER SITE. ANTIBIOTICS WERE PRESCRIBED WHICH SUCCESSFULLY TREATED THE INFECTIONS. ALTHOUGH THE PATIENT STATES ADEQUATE PAIN RELIEF, AN EXPLANT IS TENTATIVELY SCHEDULED FOR (B)(6) 2024 TO PREVENT ANY FURTHER COMPLICATIONS.

    Patient problems: Skin Infection

    MAUDE report 20433568 ↗
  • InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE COMMERCIAL TEAM MEMBER REPORTED A PATIENT WAS GOING TO HAVE THEIR NEUROSTIMULATORS EXPLANTED. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PATIENT FOR ADDITIONAL INFORMATION WITHOUT SUCCESS. THE COMMERCIAL TEAM MEMBER NOTED THE PATIENT HAD SOME PROBLEMS WITH OVERSTIMULATION IN THE PAST AND THE TRANSMITTER SETTINGS WERE ADJUSTED ACCORDINGLY. ADDITIONALLY, THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED ABDOMINAL INFECTION AND UNDERWENT SURGERIES FOR UNRELATED INTESTINAL/GASTRIC ISSUES. AFTER THESE ISSUES, THE PATIENT STOPPED USING THEIR DEVICE. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Electric Shock

    MAUDE report 20152889 ↗
  • InjuryAug 14, 2024Fracture; Use of Device Problem; Fracture; Use of Device Problem

    THE PATIENT REPORTED AN ABSCESS ON THEIR LOWER BACK. ANTIBIOTICS WERE PRESCRIBED AND A GENERAL SURGEON PERFORMED AN INCISION AND DRAINAGE (I&D) OF THE ABSCESS. CULTURES WERE OBTAINED WHICH REVEALED STAPH AUREUS POSITIVE CULTURES. ADDITIONALLY, DURING THE PROCEDURE, THE SURGEON PULLED OUT A PENCIL ERASER SIZED POWER UNIT. THE PATIENT WAS REFERRED BACK TO THEIR IMPLANTING CLINICIAN FOR FOLLOW-UP. DURING THEIR FOLLOW-UP APPOINTMENT ON (B)(6) 2024, X-RAYS WERE OBTAINED WHICH REVEALED THE PATIENT HAD NON-CURONIX SCS LEADS AS WELL AS ANOTHER UNIDENTIFIABLE LEAD IN THE PELVIS. AS OF (B)(6) 2024, THE PATIENT IS UNDER THE CARE OF INFECTIOUS DISEASE, TAKING ORAL ANTIBIOTICS, AND RECEIVING WOUND CARE. THE PATIENT IS NOT USING THEIR DEVICE AND AN EXPLANT PROCEDURE WILL BE PERFORMED ONCE THE INFECTION SETTLES. HOWEVER, A DATE HAS NOT YET BEEN SCHEDULED.

    Patient problems: Abscess; Bacterial Infection

    MAUDE report 19984474 ↗
  • InjuryJul 18, 2024Migration; Migration

    THE PATIENT STOPPED WEARING THEIR DEVICE A YEAR AGO AS THEY STATED IT NEVER REALLY WORKED FOR THEM. ATTEMPTS WERE MADE TO CHANGE THE TRANSMITTER ASSEMBLY PROGRAMS WITHOUT SUCCESS. HOWEVER, THEY REPORTED PAIN AND FEELING A SHOCKING SENSATION WITHOUT WEARING THE DEVICE. THE PATIENT WOULD LIKE AN EXPLANT PROCEDURE ALTHOUGH A DATE HAS NOT BEEN SCHEDULED. THE TRANSMITTER ASSEMBLIES WERE DISCARDED AND ARE NOT AVAILABLE FOR INVESTIGATION.

    Patient problems: Electric Shock; Pain

    MAUDE report 19774737 ↗
  • InjuryJul 18, 2024Use of Device Problem; Migration; Use of Device Problem; Migration

    THE PATIENT REPORTED THEY CAN SEE AND FEEL ONE OF THEIR NEUROSTIMULATORS NEAR THE SURFACE OF THE SKIN AND MIGRATION WAS CONFIRMED. THE PATIENT DOES NOT NEED OR USE THE PNS SYSTEM AND REQUESTED AN EXPLANT PROCEDURE. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2024 WITH NO COMPLICATIONS.

    Patient problems: Erosion

    MAUDE report 19774677 ↗
  • InjuryJun 27, 2024Use of Device Problem; Use of Device Problem

    THE PATIENT REPORTED OVERSTIMULATION. THE COMMERCIAL TEAM MEMBER MET WITH THE PATIENT ON (B)(6) 2024 AND THE CHANGED THE TRANSMITTER PROGRAMS. SINCE THE TRANSMITTER PROGRAMS WERE CHANGED, THE ISSUE HAS RESOLVED.

    Patient problems: Electric Shock

    MAUDE report 19629140 ↗
  • InjuryJun 27, 2024Fracture; Fracture

    THE PATIENT REPORTED CRAMPING AFTER A SPINAL FUSION ON (B)(6) 2024 AND REQUESTED REPROGRAMMING. ON (B)(6) 2024 REPROGRAMMING ATTEMPTS WERE MADE WITHOUT SUCCESS AND AN X-RAY PROCEDURE WAS PERFORMED WHICH SHOWED A SEVERED NEUROSTIMULATOR ON THE LEFT SIDE. THE NEUROSTIMULATOR ON THE RIGHT WAS NOT SEEN ON THE X-RAY. THE PHYSICIAN BELIEVES THE RIGHT NEUROSTIMULATOR WAS EXPLANTED AND THE LEFT NEUROSTIMULATOR WAS SEVERED DURING THE SPINAL FUSION. IT IS UNKNOWN WHICH DEVICE WAS SEVERED DURING THE PROCEDURE, THEREFORE, BOTH DEVICES ARE REPORTED. THE PATIENT WAS STILL USING THE DEVICE AFTER THE SPINAL FUSION WITH NO RELIEF. THE PATIENT WOULD LIKE TO BE IMPLANTED WITH A NEW NEUROSTIMULATOR AND THEY WILL DISCUSS OPTIONS FOR THE REMOVAL OF THE SEVERED NEUROSTIMULATOR.

    Patient problems: Cramp(s) /Muscle Spasm(s)

    MAUDE report 19629125 ↗
  • InjuryMay 24, 2024Migration; Migration

    THE PATIENT REPORTED HIP PAIN AND MIGRATION OF THE LEFT SIDE NEUROSTIMULATOR WAS CONFIRMED VIA X-RAY. ATTEMPTS WERE MADE TO REPROGRAM THE TRANSMITTER WITH NO SUCCESS. THE PATIENT WOULD LIKE TO HAVE A REVISION PROCEDURE AS THE DEVICE DID WORK PREVIOUSLY. ALTHOUGH SLIGHT MIGRATION WAS CONFIRMED ON THE RIGHT NEUROSTIMULATOR, THE PATIENT IS STILL GETTING GOOD PAIN RELIEF ON THE CURRENT PROGRAMS. THE PATIENT IS WAITING TO HEAR FROM A PHYSICIAN REGARDING THE REVISION PROCEDURE.

    Patient problems: Pain

    MAUDE report 19390364 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171366. One submission often covers many models, so check the product and lot details in each record.

  • Z-2932-2020 · Jul 15, 2020 · Open, Classified
    StimQ 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-2933-2020 · Jul 15, 2020 · Open, Classified
    StimQ 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, Classified
    StimQ 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
  • Z-2930-2020 · Jul 15, 2020 · Open, Classified
    StimQ 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, Classified
    StimQ 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-2929-2020 · Jul 15, 2020 · Open, Classified
    StimQ 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

Other Stimulator, Peripheral Nerve, Implanted (Pain Relief) devices

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Sources and updates

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