Senza TLEAD1058-50B (UDI 00813426021098)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00813426021098), received between Apr 3, 2025 and Sep 30, 2026 — classified as 13 injuries.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection at the lead incision site. A medical assessment from the physician regarding the nature of the infection was not available. The patient was initially treated with oral antibiotics; however, the infection did not resolve. The patient was subsequently hospitalized, treated with IV antibiotics, and underwent lead extraction. No further complications related to this event have been reported.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50945752 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Burning Sensation; Nerve Damage; Pain

  MAUDE report 50903660 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50860404 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection at the lead site during the trial phase. The patient was hospitalized, the device was removed, and the patient was treated with IV antibiotics. No further complications related to this event have been reported.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50804988 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION IN THE LEAD SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25113516 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS, TINGLING AND CHEST PAIN. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Chest Pain; Paresthesia

  MAUDE report 24889720 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEG PAIN FOLLOWING THE TRIAL PROCEDURE. AS A RESULT, THE PATIENT WAS TREATED WITH IV MEDICATION, AND THE LEADS WERE REMOVED THAT SAME DAY. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Limb Pain

  MAUDE report 24857948 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAKAGE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24643265 ↗
• InjuryDec 9, 2025Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  ADDITIONAL INFORMATION PROVIDED PER THE PATIENT, THEY BELIEVE EVERYTHING WAS REMOVED. THERE WERE NO XRAYS TO CONFIRM. THE PATIENT SAID THE LEAD WAS BROKEN BUT ALL PARTS SEEMED TO BE ACCOUNTED FOR AND NO LONGER IMPLANTED. THE PATIENT IS CURRENTLY IN A NURSING HOME / REHAB FACILITY DUE TO A FOOT ULCER AND WILL FOLLOW UP WITH TRIALING PHYSICIAN WHEN SHE IS SENT HOME. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761286 ↗
• InjuryDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL END OF THE LEAD TIP DETACHED INSIDE THE SUBCUTANEOUS TISSUE OF THE PATIENT. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694073 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK AT THE LEAD SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD ONE LEAD REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 23067477 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATED THAT, PER HCP, THE HEADACHES WERE NOT DEVICE RELATED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 22207635 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF A HEADACHE THAT WORSENED WHEN UPRIGHT ALONG WITH NAUSEA AND VOMITING. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE HCP DOES NOT BELIEVE THE HEADACHE WAS CAUSED BY THE DEVICE. THE PATIENT RECEIVED A BLOOD PATCH AND HAD THE DEVICE REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Headache; Nausea; Vomiting

  MAUDE report 21766690 ↗