Senza TLEAD1058-70B (UDI 00813426021104)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813426021104), received between Jul 11, 2025 and Mar 10, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE DEVELOPED AN INFECTION OR EXPERIENCED AN ALLERGIC REACTION DURING THE TRIAL PHASE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF THE EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 24561243 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE HEADACHE AND NAUSEA AND DEVELOPED A BACTERIAL INFECTION AT THE LEAD SITE WITH IDENTIFIED DRAINAGE THAT LED TO REMOVAL OF THE LEADS. THE PATIENT WAS HOSPITALIZED. CULTURES CONFIRMED A GRAM-POSITIVE COCCI INFECTION THAT PROGRESSED TO AN EPIDURAL ABSCESS, REQUIRING LAMINECTOMY AND ANTERIOR AND POSTERIOR FUSION. THE PHYSICIAN ASSESSED THE EVENT AS DEVICE-RELATED. THE PATIENT RECOVERED FROM THE INFECTION AND REMAINS UNDER PAIN MANAGEMENT.

  Patient problems: Abscess; Bacterial Infection; Headache; Nausea

  MAUDE report 23649965 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A TRIAL LEAD BREAKAGE IN HALF. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE TRIAL DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22482118 ↗