Senza LEAD1058-50BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 00813426020725), received between Jun 1, 2022 and Sep 22, 2026 — classified as 139 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 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 145 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection at the lead incision site. The physician believed that the infection was related to the implant surgery. The patient was admitted to the hospital, and the device was removed. The patient was treated with intravenous antibiotics. No further complications related to this event have been reported.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50853957 ↗
• MalfunctionJun 30, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LEAD FRACTURE. A HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE LEAD WAS REMOVED FROM THE PATIENT'S BODY. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664268 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE AND EXPERIENCED WOUND DEHISCENCE. THE LEADS WERE REMOVED, AND AS OF (B)(6) 2026, FOLLOWING A HEALING PERIOD, THE PATIENT WAS RE-IMPLANTED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; Unspecified Infection; Wound Dehiscence

  MAUDE report 25153857 ↗
• InjuryFeb 9, 2026Adverse 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 AS AN EPIDURAL ABSCESS. THE PATIENT WAS HOSPITALIZED AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Abscess; Insufficient Information; Unspecified Infection

  MAUDE report 24299491 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED A STAPHYLOCOCCUS INFECTION. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED, UNDERWENT A REVISION AND A WASHOUT PROCEDURE, AND WAS TREATED WITH BOTH ORAL AND IV ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 24222900 ↗
• InjuryJan 23, 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 24163193 ↗
• InjuryJan 19, 2026Adverse 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 24109287 ↗
• InjuryJan 19, 2026Adverse 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 24109127 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 BOTH ORAL AND INTRAVENOUS ANTIBIOTICS, AND THE DEVICE WAS REMOVED. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23837920 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE, ALONG WITH A SUSPECTED INFECTION. ACCORDING TO THE MEDICAL ASSESSMENT, THE REPORTED EVENT IS NOT BELIEVED TO BE DEVICE-RELATED. THE PATIENT UNDERWENT A WOUND WASHOUT, WAS TREATED WITH BOTH ORAL AND IV ANTIBIOTICS, AND HAD THE DEVICE REMOVED. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 23778956 ↗
• InjuryDec 8, 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 WAS HOSPITALIZED, RECEIVED IV ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23744336 ↗
• InjuryNov 12, 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 DEVELOPED AN INFECTION. THE APP BELIEVES THIS WAS DUE TO POOR HEALING AT THE MIDLINE INCISION SITE, POSSIBLY RELATED TO PICKING AT THE INCISION SCAB. THE PATIENT WAS HOSPITALIZED AND THE DEVICE WAS REMOVED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED RELATED TO THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23531255 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE HEADACHES, WHICH LED TO A HEAD CT THAT REVEALED A CEREBROSPINAL FLUID (CSF) LEAK. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A BLOOD PATCH, AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 23439022 ↗
• InjuryOct 21, 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 A MRSA 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: Bacterial Infection; Insufficient Information

  MAUDE report 23353853 ↗
• InjurySep 12, 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 HAD THE DEVICE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23040586 ↗
• InjurySep 4, 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; Swelling/ Edema; Unspecified Infection

  MAUDE report 22968878 ↗
• InjuryAug 26, 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. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT UNDERWENT A BLOOD PATCH. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 22897858 ↗
• InjuryAug 14, 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. THE PATIENT IS ALLERGIC TO THE STAPLES AND ADHESIVE USED TO CLOSE THE INCISION, WHICH THE DOCTOR BELIEVES CAUSED THE INFECTION. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS, AND THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22809413 ↗
• 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 A SKIN INFECTION AT THE LEAD INCISION SITE. THE DOCTOR BELIEVES IT MAY BE DUE TO SUPERFICIAL SKIN INFECTION FROM PATIENT'S BELT RUBBING ON MIDLINE INCISION THAT GOT INTO THE INCISION. THE PATIENT HAD THE LEADS EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Skin Infection

  MAUDE report 22779137 ↗
• InjuryAug 8, 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 WAS HOSPITALIZED, RECEIVED IV ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22753040 ↗
• InjuryJul 31, 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. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22682768 ↗
• InjuryJul 31, 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 WAS HOSPITALIZED, RECEIVED IV AND ORAL ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22679356 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION INDICATES THAT THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND UNDERWENT A DEVICE REPLACEMENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22664165 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN HEMATOMA AT THE LEAD SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT UNDERWENT AN ASPIRATION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 22638268 ↗
• InjuryJul 3, 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, UNDERWENT A PROCEDURE TO ATTEMPT TO "CLEAR OUT" INFECTION AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 22397075 ↗