StimQ Spare Lead Kit Channel B US w/Receiver STQ4-SPR-B0Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00818225020495), received between Mar 19, 2019 and Apr 16, 2026 — classified as 126 injuries.

The most frequently reported specific device problem is “Migration” (11 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED FEELING WARMTH AND A TINGLING SENSATION DURING AN MRI PROCEDURE. THE MRI WAS ABORTED IMMEDIATELY AND THE TINGLING AND WARMTH AT THE IMPLANT SITE ARE GONE. ON (B)(6) 2026, THE COMMERCIAL TEAM MEMBER MET THE PATIENT. THE PATIENT REPORTED THEY ARE STILL FEELING A TINGLING SENSATION WHEN USING THE DEVICE AND NOT RECEIVING MUCH THERAPY. THE PROGRAMS WERE CHANGED ON THE TRANSMITTER ASSEMBLY. AS OF ON (B)(6) 2026, THE PATIENT REPORTED THEIR PAIN IS DOING BETTER AND THEY ARE NOT FEELING THE BUZZING OR TINGLING SENSATION SINCE THE PROGRAMS WERE CHANGED ON THE TRANSMITTER ASSEMBLY.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 24897028 ↗
• InjuryOct 23, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED CELLULITIS DISTAL TO THE IMPLANT, WHICH LED TO AN INFECTION AT THE RECEIVER SITE. ANTIBIOTICS WERE PRESCRIBED AND AS OF (B)(6) 2025, THE PATIENT IS FINE AND THE INFECTION AND CELLULITIS ARE CLEARING.

  Patient problems: Cellulitis; Skin Infection

  MAUDE report 23368965 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A WOUND NEAR THEIR ANKLE WHICH BEGAN EIGHT MONTHS AGO FOLLOWING CELLULITIS WHICH CAUSED SIGNIFICANT EDEMA. THE PATIENT WAS PRESCRIBED MULTIPLE ROUNDS OF ANTIBIOTICS WITHOUT IMPROVEMENT AND IS CURRENTLY RECEIVING LYMPHATIC TREATMENT WITH WRAPS AND HAS NOT WORN THE DEVICE FOR OVER A YEAR. AS OF (B)(6) 2025, ANTIBIOTIC AND ANTI-INFLAMMATORY CREAM WAS APPLIED TO THE WOUND, THE PATIENT WILL FOLLOW-UP AND IS VERY THANKFUL AND HOPEFUL THE IMPLANTING CLINICIAN WILL GET THE WOUND HEALED. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 07, 2025. THE WOUND TESTED POSITIVE FOR MRSA. HOWEVER, THE REDNESS HAS GONE DOWN AND THE PATIENT WILL CONTINUE TO USE THE ANTIBIOTIC CREAM WITH THE ANTI-INFLAMMATORY AS WELL.

  Patient problems: Cellulitis; Drug Resistant Bacterial Infection; Swelling/ Edema

  MAUDE report 23302166 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN MRI FACILITY WAS MADE AWARE THAT THE PATIENT PREVIOUSLY EXPERIENCED AN INFECTION IN THEIR RIGHT LEG. AN EXPLANT PROCEDURE WAS PERFORMED AND A PORTION OF THE DEVICE REPORTEDLY REMAINS IMPLANTED. IT IS UNKNOWN WHEN THE EXPLANT WAS PERFORMED AND THE CLINIC HAS NO RECORD OF AN EXPLANT PROCEDURE. THE COMMERCIAL TEAM MEMBER HAS MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT. HOWEVER, THE ATTEMPTS HAVE BEEN UNSUCCESSFUL.

  Patient problems: Skin Infection

  MAUDE report 22923134 ↗
• InjuryAug 27, 2025Expulsion; Expulsion

  THE PATIENT REPORTED EROSION THROUGH THE SKIN. THE COMMERCIAL TEAM MEMBER IS TRYING TO FIGURE OUT A DOCTOR FOR THE PATIENT. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Erosion

  MAUDE report 22909517 ↗
• InjuryMar 6, 2025Use of Device Problem; Migration; Use of Device Problem; Migration

  THE PATIENT REPORTED THEIR NEUROSTIMULATOR HAS MIGRATED CLOSE TO THE SURFACE OF THE SKIN WHICH CAUSES SENSITIVITY AND IRRITATION FROM RUBBING ON SOCKS AND SHOES. ADDITIONALLY, THE PATIENT REPORTED UNCOMFORTABLE STIMULATION AND THEY HAVE NOT WORN THE DEVICE FOR OVER SIX MONTHS. THE PATIENT HAS MOVED TO ANOTHER STATE AND HAS ESTABLISHED CARE WITH A PRACTICE THAT IS WILLING TO DO AN EXPLANT OR A REVISION PROCEDURE. HOWEVER, THE PROCEDURE HAS NOT YET BEEN APPROVED OR SCHEDULED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21542663 ↗
• InjuryFeb 7, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED EROSION, REDNESS, MINOR SWELLING, AND A POSSIBLE INFECTION AT THE INCISION SITE. DURING THE PATIENT'S FOLLOW-UP APPOINTMENT ON (B)(6) 2025, AN INFECTION WAS NOT PRESENT, EROSION WAS NOT CONFIRMED, ANTIBIOTICS WERE NOT PRESCRIBED, AND INTERVENTION WAS NOT NECESSARY. THE REDNESS IS GONE, THE PATIENT IS RECEIVING GREAT PAIN RELIEF AND IS BEING VERY ACTIVE.

  Patient problems: Erosion; Skin Infection; Swelling/ Edema

  MAUDE report 21337064 ↗
• InjuryDec 3, 2024Off-Label Use; Off-Label Use

  THE PATIENT REPORTED PAIN AT THE IMPLANT LOCATION. AN EXPLANT PROCEDURE WILL BE PERFORMED ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 20835289 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEY SAW A DERMATOLOGIST IN (B)(6) DUE TO AN ABSCESS THAT WAS GROWING IN THEIR RECEIVER INCISION. ON (B)(6) 2024, THE DERMATOLOGIST OPENED THE RECEIVER POCKET, EXPOSED THE NEUROSTIMULATOR, AND DRAINED AND REMOVED THE ABSCESS. A CULTURE AND SAMPLE OF THE ABSCESS WERE TAKEN AND ANTIBIOTICS WERE PRESCRIBED. HOWEVER, THERE WERE NO SIGNS OF INFECTION PRESENT AND THE ABSCESS WAS BENIGN. ON (B)(6) 2024 THE PATIENT HAD A FOLLOW-UP APPOINTMENT FOR AN INCISION CHECK. THE INCISION LOOKED RED, SWOLLEN, PAINFUL, AND WARM. THE DERMATOLOGIST PRESCRIBED ANOTHER ROUND OF ANTIBIOTICS AND INSTRUCTED THE PATIENT TO FOLLOW-UP WITH THEIR IMPLANTING CLINICIAN. DURING THEIR APPOINTMENT ON (B)(6) 2024, ANOTHER ABSCESS/LESION WAS FORMING. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2024 AND THE PATIENT IS HEALING WELL.

  Patient problems: Abscess

  MAUDE report 20644420 ↗
• InjuryOct 2, 2024Off-Label Use; Off-Label Use

  THE PATIENT REPORTEDLY FELT A "POP" SENSATION AND HAS SINCE EXPERIENCED PAIN AND LOSS OF THERAPY. THE TRANSMITTER SETTINGS WERE CHANGED AND ALTHOUGH THE PATIENT IS STILL IN SOME PAIN, THE PAIN HAS REDUCED. THE PATIENT WILL FOLLOW-UP WITH THE IMPLANTING CLINICIAN FOR NEXT STEPS AND THEY ARE AWAITING APPROVAL FROM THEIR CARDIOLOGIST FOR AN EXPLANT PROCEDURE.

  Patient problems: Pain

  MAUDE report 20356195 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED A BURNING SENSATION NEAR THE NEUROSTIMULATOR WHETHER THE DEVICE IS ON OR OFF DEPENDING ON HOW THEY SIT. THE PATIENT IS RECEIVING 80% RELIEF AND WAS INSTRUCTED TO MAKE AN APPOINTMENT WITH THEIR DOCTOR. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Burning Sensation

  MAUDE report 20047897 ↗
• InjuryMay 13, 2024Off-Label Use; Off-Label Use

  THE PATIENT REPORTED MAJOR HEAD PAIN FOR THREE DAYS DESPITE USING THE DEVICE REGULARLY AND TAKING TWO HEAVY PAIN MEDICINES. ADDITIONALLY, THE PATIENT REPORTED POTENTIAL MIGRATION AS THE PATIENT WAS IMPLANTED IN THE FOREHEAD AND FEELS THE NEUROSTIMULATOR ABOVE THE EYEBROW. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THERE HAVE BEEN MULTIPLE ATTEMPTS TO CONTACT THE PATIENT WITH NO SUCCESS.

  Patient problems: Pain

  MAUDE report 19304319 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THE INCISION SITE. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2024. THE PATIENT IS STILL HEALING.

  Patient problems: Skin Infection

  MAUDE report 19114523 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED AN INFECTION AT THE INCISION SITE. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2024. THE PATIENT IS HEALING AND THE PHYSICIAN PLANS TO IMPLANT A NEW NEUROSTIMULATOR AFTER THE PATIENT HAS HEALED.

  Patient problems: Skin Infection

  MAUDE report 18975321 ↗
• InjuryJan 18, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED THEY STOPPED USING THE DEVICE DUE TO REDNESS AND BLISTERING AT THE SURGICAL SITE. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE IS TENTATIVELY SCHEDULED FOR (B)(6) 2024. ALTHOUGH THE PATIENT DID NOT HAVE ANY REDNESS OR BLISTERING AT THEIR LAST FOLLOW UP, THEY WOULD LIKE THE DEVICE EXPLANTED TO AVOID ANOTHER "FLARE UP" SINCE THEY CANNOT TOLERATE ANYTHING OVER THEIR SKIN.

  Patient problems: Blister

  MAUDE report 18535809 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED REDNESS AND DRAINAGE AT THE SITE. THE PATIENT WENT TO THE EMERGENCY ROOM, ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6), 2023. THE INFECTION IS CLEARING.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18178196 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PAIN AND AN OPENING OF THE SKIN AND EXPOSURE OF THE LEAD AFTER STRETCHING. THE CLINICIAN CLEANED OUT THE WOUND AND RESTITCHED IT. THE PATIENT WAS NOT GIVEN ANTIBIOTICS, THE WOUND HAS HEALED, AND THE PATIENT IS GETTING ADEQUATE THERAPY.

  Patient problems: Erosion; Pain

  MAUDE report 18096543 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THE LEADS ERODED THROUGH THE POCKET SITE. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2023. THE PATIENT IS DOING WELL AND THE SITE APPEARS TO BE HEALING NICELY.

  Patient problems: Erosion

  MAUDE report 17996866 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PAIN AT THE INCISION SITE. THE PATIENT HAS NOT USED THERAPY SINCE THE PERMANENT DEVICE WAS IMPLANTED. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6), 2023. THE PATIENT IS DOING FINE AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 17977064 ↗
• InjuryOct 18, 2023Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED A LOSS OF THERAPY AND MIGRATION WAS CONFIRMED VIA X-RAY. ON (B)(6) , 2023, IT WAS REPORTED THAT THE MIGRATION RESULTED IN THE SKIN BEING PIERCED FROM THE INSIDE OUT WHICH CAUSED NEW PAIN AND SIGNS OF EROSION. THE PATIENT REPORTED THAT THE PAIN AREA WAS RED AND VERY PAINFUL BUT THE SKIN WAS NOT PUNCTURED. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2023. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 17961358 ↗
• InjuryOct 17, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EROSION. INFECTION WAS NOT CONFIRMED. HOWEVER, ANTIBIOTICS WERE PRESCRIBED, AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6), 2023, AND NEW LEADS WERE IMPLANTED. THE PATIENT IS DOING WELL AND RESTARTED THERAPY ON (B)(6), 2023.

  Patient problems: Erosion

  MAUDE report 17952493 ↗
• InjuryOct 11, 2023Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED DISCOMFORT CAUSED BY THE IMPLANT. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2023. THE PATIENT IS STILL SENSITIVE FROM REMOVAL OF THE LEADS.

  Patient problems: Discomfort

  MAUDE report 17915402 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EROSION. ANTIBIOTICS WERE PRESCRIBED AND AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Erosion

  MAUDE report 17914638 ↗
• InjurySep 27, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT REPORTED PAIN FROM THEIR SHOULDER DOWN TO THEIR HAND. THE PATIENT WAS INSTRUCTED TO TURN THE DEVICE OFF FOR 24 HOURS. MIGRATION WAS CONFIRMED. HOWEVER, REPROGRAMMING ATTEMPTS WERE MADE AND THE PATIENT IS RECEIVING THERAPY AGAIN.

  Patient problems: Pain

  MAUDE report 17829970 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED ONE OF THEIR LEADS STARTED TO ERODE THROUGH THE SKIN. ALTHOUGH EROSION WAS NOT CONFIRMED AND NO INFECTION WAS PRESENT, THE KNOT AROUND THE B LEAD WAS PUSHING AGAINST THE SKIN CAUSING A BUBBLE. AN EXPLANT PROCEDURE WAS PERFORMED ON (B)(6), 2023, TO REMOVE THE B LEAD. THE PATIENT STILL FELT ADEQUATE STIMULATION IN THEIR PAIN AREA SO ANOTHER LEAD WAS NOT IMPLANTED. THE PATIENT IS HEALING UP WELL FROM SURGERY.

  Patient problems: Erosion

  MAUDE report 17785361 ↗

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-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
• 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-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-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-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