Senza LEAD1058-90BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813426020756), received between Sep 4, 2024 and Apr 3, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE LEAD INCISION SITE. 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 24776190 ↗
• InjuryDec 11, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISCOMFORT CAUSED BY AN ORPHANED LEAD. DURING THE REVISION, A FRACTURED LEAD WAS ALSO IDENTIFIED. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE DEVICE WAS REMOVED, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Discomfort

  MAUDE report 23777494 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CFS LEAK. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT RECEIVED A BLOOD PATCH AND IS DOING WELL SINCE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21845055 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND HEALING ISSUES AT THE UPPER INCISION FOR CERVICAL LEAD. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PHYSICIAN REMOVED THE ENTIRE SYSTEM TO BE SAFE INCLUDING THE THORACIC LEADS AND TOLD PATIENT HE WOULD RE IMPLANT ONCE SHE COMPLETELY HEALS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 21529800 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PORTION OF LEAD THAT ¿ERODED THROUGH THE SKIN¿ ADJACENT TO UPPER INCISION. THE PHYSICIAN BELIEVES IT COULD BE RELATED TO PATIENT'S HISTORY OF COCAINE USAGE. THERE WERE NO APPARENT SIGNS OF INFECTION. 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: Skin Erosion

  MAUDE report 20798534 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN STAPH INFECTION AT THE LEAD INCISION SITE. THE PATIENT UNDERWENT A WOUND WASHOUT AND WAS TREATED WITH IV AND ORAL ANTIBIOTICS AND HAD THE LEADS EXPLANTED, THE DEVICE WAS LEFT IN SITU. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION TO BE DEVICE RELATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 20153117 ↗
• InjurySep 4, 2024Adverse 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 PATIENT RECEIVED ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20137256 ↗