Senza TLEAD1058-50B (UDI 00813426020732)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00813426020732), received between Nov 17, 2021 and Mar 13, 2026 — classified as 32 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A CERVICAL SPINAL CORD STIMULATOR TRIAL, AN EXPIRED PERCUTANEOUS TRIAL LEAD WAS IMPLANTED IN THE PATIENT. THE EXPIRED STATUS WAS DISCOVERED DURING PRODUCT ENTRY INTO INTERNAL SYSTEMS. THE PHYSICIAN AND PATIENT WERE NOTIFIED IMMEDIATELY. ALTHOUGH THE PHYSICIAN WAS COMFORTABLE CONTINUING THE TRIAL, THE PATIENT ELECTED TO STOP THERAPY, AND THE LEAD WAS REMOVED THE NEXT DAY. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595948 ↗
• MalfunctionDec 19, 2023Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  THREE GOOD FAITH EFFORT ATTEMPTS WERE MADE TO ATTEMPT TO GATHER MORE INFORMATION REGARDING THE RETURN OF THE TLEAD1058-50B IN THIS CASE. THE DEVICE WAS NOT AVAILABLE FOR RETURN.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18360881 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISSUES WITH BLOOD PRESSURE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE TRIAL WAS ABORTED AND THE USED LEAD WAS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 17921840 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WORSENED SHOULDER PAIN AND NERVE IRRITATION. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE TRIAL WAS ABORTED AND THE LEADS WERE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 17909035 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DURAL PUNCTURE AS THE PHYSICIAN WAS TRYING TO ADVANCE THE NEEDLE INTO THE EPIDURAL SPACE. LATER, THE PATIENT RECEIVED A BLOOD PATCH AND WAS THEN TRANSFERRED TO THE EMERGENCY FOR INCREASED PAIN BEFORE DISCHARGE FROM THE FACILITY. THE DEVICE WAS TURNED OFF BEFORE THE HOSPITAL TRANSFER. A FEW DAYS LATER, THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD PRESSURE, NECK PAIN, AND HEADACHES. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. LEADS WERE EXPLANTED AND THE TRIAL WAS ABORTED BECAUSE THE HEADACHES CONTINUED. ANOTHER BLOOD PATCH WAS DONE THE SAME DAY AS THE EXPLANT. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; High Blood Pressure/ Hypertension; Neck Pain; Pain

  MAUDE report 17904532 ↗
• MalfunctionSep 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AN ABANDONED AND BROKEN TRIAL LEAD WAS DISCOVERED WITHIN THE PATIENT. THE LEAD WAS LEFT IN PLACE AND THERE ARE NO PLANS TO REMOVE THE DEVICE AS THE PHYSICIAN HAS NO CONCERNS WITH THE DEVICE REMAINING IN THE PATIENT. THE IMPLANTATION PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT. THE PATIENT IS CURRENTLY USING THEIR DEVICE WITHOUT ANY ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 17809012 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTREME PAIN IN CALVES AND FEET BILATERALLY. PATIENT HAD THE LEADS REMOVED APPROXIMATELY 1 HOUR AFTER THEY WERE PLACED WHICH DID NOT RESOLVE THE PAIN. PATIENT WAS HOSPITALIZED AND HAD SURGERY THE FOLLOWING DAY TO EVACUATE A HEMATOMA. PER HCP ASSESSMENT THE CAUSE OF THE REPORTED HEMATOMA IS NOT DEVICE RELATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma; Pain

  MAUDE report 17795046 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE LEAD INCISION SITE. THE HCP BELIEVES THAT THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS HOSPITALIZED AND RECEIVED IV ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17484093 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA AT THE INCISION SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT UNDERWENT SURGERY TO REMOVE THE HEMATOMA. ACCORDING TO THE REFERRING PHYSICIAN, THIS EMERGENT EVENT HAS BEEN RESOLVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS.

  Patient problems: Hematoma

  MAUDE report 17452584 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UPPER BACK PAIN, NECK PAIN, CHEST PAIN, AND RIGHT ARM NUMBNESS AFTER THE TRIAL PROCEDURE. THE HCP BELIEVES THE ISSUES TO BE RELATED TO AIR INJECTED WHEN HE WAS GETTING LOSS OF RESISTANCE DURING THE TRIAL. THE TRIAL LEADS WERE PULLED PREMATURELY. THE PATIENT'S SYMPTOMS PERSISTED AFTER THE LEAD PULL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Chest Pain; Neck Pain; Numbness; Pain

  MAUDE report 17447173 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POST-OP BILATERAL LOWER EXTREMITY PAIN. THE PHYSICIAN DOES NOT BELIEVE THE REPORTED SYMPTOM TO BE DEVICE-RELATED, AS THE DEVICE WAS TURNED OFF. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 17393761 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEG PAIN DURING THE TRIAL PROCEDURE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DEVICE WAS REMOVED AND THE TRIAL WAS ABORTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 17148568 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STOPPED BREATHING DURING THE TRIAL PROCEDURE DUE TO ANESTHESIA LEVELS AND/OR POSSIBLE STROKE. THE HCP DOES NOT BELIEVE THE REPORTED EVENT WAS DEVICE RELATED. HOWEVER, ONE LEAD WAS IN CONTACT WITH THE PATIENT DURING THE REPORTED EVENT. THE PATIENT WAS HOSPITALIZED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 17062052 ↗
• InjuryMay 10, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION. ADDITIONAL INFORMATION FROM THE PHYSICIAN REGARDING THE NATURE OF THE LEAD MIGRATION WAS NOT AVAILABLE. THE LEADS WERE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16907716 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEADS WERE REMOVED DUE TO INCREASED PAIN AND TREMORS ON THE LEFT LEG. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE REPORTED SYMPTOMS AND LEADS REMOVAL WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain; Shaking/Tremors

  MAUDE report 16818264 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED DUE TO MID-BACK PAIN AND LEG WEAKNESS. PER THE PHYSICIAN, THESE SYMPTOMS WERE NOT DEVICE-RELATED. THE MID-BACK PAIN AND LEG WEAKNESS RESOLVED AFTER LEAD REMOVAL. HOWEVER, THE MID-BACK PAIN RETURNED AND THE PATIENT WAS HOSPITALIZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 16800446 ↗
• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO PLACE THE LEAD DURING THE TRIAL PROCEDURE, THE LEAD FRACTURED AND THE DISTAL END OF THE LEAD REMAINED IN THE PATIENT. THE TRIAL WAS COMPLETED SUCCESSFULLY AND THE PHYSICIAN PLANS TO REMOVE THE DETACHED PORTION OF THE LEAD AT THE TIME OF THE PERMANENT IMPLANT SURGERY. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16651848 ↗
• InjuryMar 22, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXCESSIVE BLEEDING. THE PHYSICIAN BELIEVES THE BLEEDING WAS CAUSED WHEN THE LOWER LEAD PULLED DOWN. THE PATIENT'S DRESSING AND TRIAL STIMULATOR WERE REPLACED DUE TO BLOOD IN THE LEAD PORTS AND ON THE BATTERY CONTACTS AND CONCERNS ABOUT BATTERY CORROSION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16595589 ↗
• MalfunctionMar 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO NEVRO THAT FOUR ELECTRODES DETACHED FROM THE LEAD. THERE WAS NO REPORTED INJURY TO THE PATIENT. BOTH LEADS WERE REMOVED, EXCEPT FOR THE DETACHED LEAD PIECE. THE PATIENT WILL BE IMPLANTED WITH AN IPG IN THE FUTURE, AT WHICH POINT THE NEUROSURGEON PLANS TO REMOVE THE DETACHED LEAD PIECE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569933 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT'S LEAD PULL, THE PATIENT WAS HOSPITALIZED FOR MENINGITIS. AN ATTEMPT WAS MADE TO GET AN HCP ASSESSMENT REGARDING THE MENINGITIS, BUT NONE WAS AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Meningitis

  MAUDE report 16538160 ↗
• InjuryFeb 15, 2023Migration; Migration

  IT WAS REPORTED THAT A PATIENT ARRIVED FOR A REGULARLY SCHEDULED LEAD PULL AND END OF THEIR TRIAL ON (B)(6) 2022. THE HEALTHCARE PROVIDER DELAYED THE LEAD PULL DUE TO CONCERNS THAT THE PATIENT TOOK ASPIRIN DURING THEIR TRIAL. ON THE SAME DAY, THE HEALTHCARE PROVIDER DISCONNECTED THE PROXIMAL END OF THE TRIAL LEADS FROM THE TSM AND TAPED THE PROXIMAL ENDS OF THE LEADS TO THE PATIENT'S BODY UNDER A STERILE DRESSING. AFTER DISCONTINUING THE ASPIRIN, THE PATIENT RETURNED FOR THE LEAD PULL ON (B)(6) 2022 AND WHEN THE DRESSING WAS REMOVED, THE LEADS WERE NOT VISIBLE. X-RAY IMAGING CONFIRMED THAT THE LEADS HAD MIGRATED INTO THE PATIENT'S BODY. THE LEADS WERE REMOVED VIA A SURGICAL PROCEDURE ON (B)(6) 2022 AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT. THE PATIENT HAS SINCE PROCEEDED TO A PERMANENT IMPLANT AND USES THE SYSTEM TO FIND EFFECTIVE PAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382616 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AFTER THE TRIAL ENDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION, BUT NONE WAS AVAILABLE. THE PATIENT WAS HOSPITALIZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16337329 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT PAIN AND SOME LEG WEAKNESS DURING THE TRIAL PROCEDURE. THE LEADS WERE REMOVED AND THE TRIAL WAS ABORTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy; Pain

  MAUDE report 16284681 ↗
• MalfunctionDec 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL WHICH FRACTURED THE PATIENT'S LEAD. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. THE LEAD WAS REMOVED AND THE TRIAL IS CURRENTLY CONTINUING WITH THE OTHER LEAD, WHICH REMAINED INTACT. THE PATIENT CONTINUES TO USE THERAPY TO FIND EFFECTIVE PAIN RELIEF AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Fall

  MAUDE report 16040609 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEADACHES AND DOUBLE VISION IN THE RIGHT EYE AFTER THEIR SCS TRIAL HAD ENDED. THE PATIENT WAS PRESCRIBED 2 DIFFERENT MEDICATIONS, WHICH DID NOT RESOLVE THE ISSUE. THE PHYSICIAN HAS ASKED THE PATIENT TO COME IN FOR A BLOOD PATCH. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage; Diplopia/Double Vision; Headache

  MAUDE report 15911947 ↗