Senza TLEAD1058-70B (UDI 00813426020749)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00813426020749), received between Apr 29, 2022 and Nov 19, 2024 — classified as 1 death, 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION INDICATED THAT THE DEVICE FRAGMENT LEFT IN PATIENT WAS SUCCESSFULLY REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727999 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTREME PAIN AT ENTRY SITE DURING THE RECOVERY PERIOD. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT'S DEVICE WAS REMOVED AND THE TRIAL ABORTED. THE PAIN WAS RELATED TO THE PROCEDURE AS THE DEVICE WAS NEVER TURNED ON. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 20170597 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED A BACTERIAL INFECTION AT THE LEAD SITE. THE PATIENT WAS HOSPITALIZED, RECEIVED IV ANTIBIOTICS AND HAD THE LEADS PULLED. THE HCP DOES NOT BELIEVE THE INFECTION WAS DEVICE-RELATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 18969966 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA AND PAIN FOLLOWING THE IMPLANT PROCEDURE, PROGRESSING TO NUMBNESS AND ULTIMATELY RESULTING IN WEAKNESS AND INABILITY TO MOVE THEIR LEGS. MRI SHOWED A LARGE EPIDURAL BLEED. ACCORDING TO THE PHYSICIAN, THESE SYMPTOMS STEMMED FROM THE IMPLANT PROCEDURE. THE TRIAL WAS ABORTED, AND THE DEVICE WAS REMOVED. THE PATIENT IS IN THE PROCESS OF RECOVERY, WITH RESTORED SENSATION AND MOBILITY. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy; Nausea; Numbness; Pain; Paralysis

  MAUDE report 18616236 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CSF LEAK DURING THE TRIAL. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. LEADS WERE EXPLANTED 1 DAY EARLIER THAN EXPECTED BECAUSE OF THIS ISSUE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18229568 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED PAIN DURING AN IMPLANT PROCEDURE, PRIMARILY ATTRIBUTED TO DISCOMFORT RELATED TO THEIR POSITIONING AND THE PLACEMENT OF THE LEAD. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE IMPLANT PROCEDURE WAS ABORTED AND THE PATIENT WAS DISCHARGED FROM THE CLINIC WITHOUT ANY SUBSEQUENT ISSUES. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 17673862 ↗
• InjuryAug 23, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION FROM BOTH LEADS AND ONE LEAD MIGRATED DURING THE TRIAL. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE LEADS WERE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17608660 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FIRST CONTACT OF THE TRIAL LEAD SHEARED OFF WHEN PULLING BACK INTO THE ACCESS NEEDLE AND WAS RETAINED IN THE PATIENT. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243418 ↗
• InjuryMay 26, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT'S LEADS MIGRATED COMPLETELY OUT OF THEIR BODY DURING THE TRIAL. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE TRIAL WAS ENDED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015025 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VERTIGO WHEN ROLLING OVER. THE PHYSICIAN REMOVED THE LEADS AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Vertigo

  MAUDE report 16538221 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DESATURATION DURING THE TRAIL PROCEDURE. THE LEADS WERE REMOVED AND THE PROCEDURE WAS REDONE WITH 2 NEW LEADS. HOWEVER, THERE WAS SOME POSSIBLE ROOT IRRITATION ON THE PATIENT'S RIGHT LEG AND THE NEW LEADS WERE REMOVED. PER THE REP, THE FAILED TRIAL WAS DUE TO A PROCEDURAL ISSUE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Low Oxygen Saturation; Pain

  MAUDE report 16448880 ↗
• DeathFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF DEATH, BUT NONE WAS AVAILABLE. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES FROM THE PATIENT PRIOR TO THE PASSING.

  Patient problems: Insufficient Information

  MAUDE report 16358628 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NEW PAIN IN THEIR LOWER RIGHT ARM POST TRIAL PROCEDURE. THE PHYSICIAN BELIEVED THE PAIN WAS DUE TO HOW TIGHT THE PATIENT'S EPIDURAL SPACE WAS AND NOT THE DEVICE ITSELF. THE PATIENT WAS HOSPITALIZED AND THEIR LEADS WERE REMOVED THE DAY AFTER THE TRIAL PROCEDURE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 16281404 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN GOING DOWN THEIR RIGHT LEG AFTER THE TRIAL PROCEDURE. ONE LEAD WAS REMOVED WHICH REDUCED THE PAIN. THE TRIAL WAS SUCCESSFULLY COMPLETED WITH THE REMAINING LEAD. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 16207828 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EPIDURAL BLEEDING AND NECK PAIN AFTER THE TRIAL LEADS WERE REMOVED. THE PHYSICIAN WAS ABLE TO STOP THE BLEEDING. HOWEVER, THE PATIENT EXPERIENCED NECK PAIN RIGHT AFTER AND WAS HOSPITALIZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Neck Pain

  MAUDE report 16164416 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE LEAD INCISION SITE DURING THE TRIAL PROCEDURE. THE LEADS WERE PULLED AND THE PATIENT RECEIVED IV MEDICATION WHICH DID NOT RESOLVE THE ISSUE. THE PATIENT WAS HOSPITALIZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain; Pain

  MAUDE report 16118706 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POSSIBLE CARDIAC ARREST FOLLOWING THE PROCEDURE. THE PHYSICIAN BELIEVES THIS WAS A RESULT OF HYPOXIA, UNRELATED TO THE DEVICE. THE PATIENT WAS ADMITTED TO THE ICU AND REMAINS UNDER MEDICAL SUPERVISION.

  Patient problems: Cardiac Arrest

  MAUDE report 15523109 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE RIGHT FOOT FOLLOWING THE IMPLANT SURGERY. THE PHYSICIAN DECIDED TO REMOVE THE LEADS AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 15474838 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT LOST SENSATION AND MOTOR FUNCTION OF THE LOWER EXTREMITIES FOLLOWING THE IMPLANT PROCEDURE. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE AND FOUND A HEMATOMA, WHICH WAS REMOVED AS WELL. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 15156651 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE OF CEREBROSPINAL FLUID. THE PHYSICIAN ADMINISTERED A BLOOD PATCH AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 15107819 ↗
• InjuryJun 30, 2022Adverse 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 SANGUINEOUS DRAINAGE AND PERSISTING PAIN. THE MANUFACTURER ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE ISSUE BUT NONE WAS AVAILABLE. THE TRIAL WAS ABORTED. THERE WERE NO REPORTS OF DEVICE-RELATED ISSUES PRIOR TO THE DEVICE REMOVAL. PT CALLS AND REPORTS SHE IS HAVING 7 IN OF SEROSANGUINOUS DRAINAGE. SHE DENIES BRIGHT RED BLOOD. SHE REPORTS THAT IT IS AN EMERGENCY AND THAT SHE WANTS TO SEE DR. (B)(6). DR. (B)(6) HAD HER COME IN AND HE REMOVED THE SCS. SHE CALLS BACK AND WANTS TO KNOW WHAT (B)(6) TOLD ME. I TOLD HER THAT ALL HE TOLD ME WAS THAT HE REMOVED IT. SHE WANTS TO TALK TO (B)(6) ABOUT DEFECTS. I TOLD HER THAT HE IS AWAY WITH HIS KIDS THIS WEEKEND. SHE WANTS TO KNOW WHEN HE IS BACK AND I TOLD HER HE WOULD BE BACK ON MONDAY. SHE STATES (B)(6) THREW THE TRIAL STIMULATOR IN THE TRASH AND THAT THE TRASH WILL BE GONE BY MONDAY. SHE TOLD ME THIS MORNING THAT THE DAY BEFORE SHE WAS IN SO MUCH PAIN. SHE STATES THAT SHE WAS VERY ACTIVE GOING TO (B)(6) OFFICE. SHE STATES THAT YESTERDAY SHE WAS ACTUALLY DRAGGING HER LEG. SHE TOLD ME THIS MORNING THAT HER PAIN WAS BETTER TODAY. SHE DENIED THAT HER PAIN

  Patient problems: Fluid Discharge; Pain

  MAUDE report 14881333 ↗
• InjuryJun 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD CLEAR DRAINAGE AT THE LEAD SITE AND DEVELOPED A CSF LEAK. THE PHYSICIAN SUSPECTED THAT THE ISSUE OCCURRED DURING LEAD INSERTION. THE PHYSICIAN CLEANED THE SKIN AND SURROUNDING TISSUE AND REMOVED THE TRIAL LEADS. THE PATIENT WAS GIVEN ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage; Fluid Discharge

  MAUDE report 14680942 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS IN THEIR LOWER EXTREMITIES DURING THE PROCEDURE. THE PROCEDURE WAS ABORTED AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

  Patient problems: Numbness

  MAUDE report 14256602 ↗