Senza LEAD1058-70BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00813426020763), received between Mar 17, 2022 and Jun 10, 2026 — classified as 82 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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. 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Fracture

  DURING A PROCEDURE UNRELATED TO THE DEVICE, IT WAS REPORTED THAT THE PATIENT¿S LEAD WAS BROKEN. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE LEAD WAS SUBSEQUENTLY REMOVED FROM THE PATIENT'S BODY. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462728 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE LEAD INCISION SITE. THE PATIENT RECEIVED ANTIBIOTICS BUT DIDN'T RECOVER AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24879663 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24861281 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION. ACCORDING TO THE MEDICAL ASSESSMENT, THE INFECTION IS NOT BELIEVED TO BE DEVICE RELATED. THE PATIENT HAD THE DEVICE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24649617 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24531486 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND PAIN AT THE LEAD SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT'S DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 24415336 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN EROSION. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Skin Erosion

  MAUDE report 24377416 ↗
• InjuryNov 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, THE PATIENT'S LEAD WAS FOUND TO BE BROKEN JUST AFTER THE LEAD ANCHOR. AN ASSESSMENT REGARDING THE CAUSE OF THE REPORTED DAMAGE WAS NOT AVAILABLE. THE DEVICE WAS REPLACED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23672054 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED THIGH PAIN IMMEDIATELY AFTER THE IMPLANT PROCEDURE. THE DEVICE WAS REMOVED AS A PRECAUTION BY THE PHYSICIAN. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Limb Pain

  MAUDE report 23671232 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED A STAPHYLOCOCCUS INFECTION DUE TO A THORACIC WOUND. THERE WAS NO INDICATION THAT THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS HOSPITALIZED AND TREATED WITH BOTH ORAL AND IV ANTIBIOTICS, AND THE DEVICE WAS REMOVED. THE PATIENT WAS DISCHARGED AND SENT TO A REHABILITATION FACILITY AND IS CURRENTLY AT HOME. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 23593814 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND NUMBNESS IN THE RIGHT LEG. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE MRI DID NOT SHOW SIGNS OF A HEMATOMA, BUT PHYSICIAN CHOSE TO REMOVE PADDLE TO REMOVE ANY POTENTIAL PRESSURE ON DEVICE. THE PATIENT WAS HOSPITALIZED AND HAD THE LEAD EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy; Numbness

  MAUDE report 23319031 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION FOR NON-INFECTIOUS REASONS. FOLLOWING REMOVAL, TESTING IDENTIFIED AN INCIDENTAL FINDING OF STAPHYLOCOCCUS CONTAMINATION ON ONE OF THE EXPLANTED LEADS. THE PATIENT EXHIBITED NO CLINICAL SIGNS OR SYMPTOMS OF INFECTION, AND THE EXPLANT WAS NOT PERFORMED TO TREAT AN ACTIVE INFECTION. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS AS A PRECAUTION AND REMAINS UNDER PHYSICIAN FOLLOW-UP. THE PHYSICIAN DOES NOT CONSIDER THE INFECTION TO BE DEVICE-RELATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 23305115 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN SCHEDULED SURGERY FOR A SECOND IMPLANT FOR HIS LUMBAR AREA, THE PHYSICIAN FOUND CEREBROSPINAL FLUID (CSF) LEAK. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT UNDERWENT A BLOOD PATCH AND THE PROCEDURE WAS ABORTED. THE PATIENT IS DOING WELL. HIS STIMULATOR FOR HIS UPPER NECK AREA IS FUNCTIONING AS IT SHOULD. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 23040116 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN EPIDURAL HEMATOMA. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT UNDERWENT A LAMINECTOMY TO DECOMPRESS THE SPINAL CORD AND HAD THE SYSTEM REMOVED. THE PATIENT IS RECOVERING WELL, WITH NO SIGNS OF NEUROLOGICAL IMPAIRMENT, AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 22840741 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE LEAD INCISION SITE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22773112 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22731172 ↗
• InjuryJul 8, 2025Adverse 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 LEFT LEG AND FOOT FOLLOWING THE IMPLANTATION PROCEDURE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE CAUSE OF THE REPORTED SYMPTOMS WAS NOT AVAILABLE. THE PATIENT WAS TRANSFERRED TO THE ICU, WHERE THEY WERE TREATED WITH INTRAVENOUS MEDICATION. THE PATIENT REMAINS HOSPITALIZED, AND NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Limb Pain

  MAUDE report 22440530 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT THE X-RAYS IMAGES SHOWED THE LEADS WERE BROKEN. 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 22214918 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION THAT PROGRESSED TO SEPSIS. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED AND TREATED WITH BOTH ORAL AND INTRAVENOUS ANTIBIOTICS. THE DEVICE WAS REMOVED, AND NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; Sepsis; Unspecified Infection

  MAUDE report 22214548 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION, AND THE WOUND IS NOT HEALING PROPERLY. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS; THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22185472 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO MOVE FEET OR BEND KNEES AFTER THE RECOVERY TRIAL INSERTION. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE TRIAL WAS ABORTED AND PATIENT HAD THE DEVICE EXPLANTED. IMMEDIATELY POST REMOVAL PATIENT'S MOVEMENT TO LEGS RETURNED FULLY AND SYMPTOMS RESOLVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Paralysis

  MAUDE report 22108758 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS IN LEGS AND A DECREASE IN REFLEXES WHEN RECOVERING FROM THE TRIAL PROCEDURE. THE REPRESENTATIVE CONFIRMED THE PROCEDURE WAS DONE WITHOUT ANY ISSUES. THE TRIAL WAS ABORTED THE SAME DAY IT STARTED AND THE SYMPTOMS SUBSIDED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22081108 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN STAPH INFECTION AT THE LEAD INCISION SITE. THE PATIENT WAS HOSPITALIZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection; Insufficient Information

  MAUDE report 22040011 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE LEAD INCISION SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS AND IS FEELING BETTER. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 21919660 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE LEAD INCISION. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 21853021 ↗