Surpass™ LEAD3005-70BRecalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 00813426020480), received between May 1, 2017 and Sep 22, 2026 — classified as 1 death, 116 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50859028 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION. PHYSICIAN BELIEVES IT COULD BE DUE TO IMPROPER CARE OF THE SURGICAL SITES AROUND THE TOP INCISION. 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 24861058 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEG PAIN FOLLOWING THE IMPLANT PROCEDURE. A CT SCAN INDICATED THAT THE PADDLE WAS EXERTING PRESSURE ON A HERNIATED DISC. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Limb Pain

  MAUDE report 24744863 ↗
• MalfunctionFeb 27, 2026Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SENSATIONS OF HEAT. A MEDICAL ASSESSMENT REGARDING THE CAUSE OF THESE SYMPTOMS WAS NOT AVAILABLE. THE DEVICE WAS REPLACED DURING A REVISION PROCEDURE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED RELATED TO THIS EVENT.

  Patient problems: Burning Sensation

  MAUDE report 24471536 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER CONNECTING LEADS TO A NEW BATTERY UPGRADE, IT WAS NOTED THAT THERE WERE TWO ELECTRODES WITH HIGH IMPEDANCES THAT PATIENT DID NOT HAVE PRIOR. WHEN THE PROVIDER EXAMINED IT, IT WAS FOUND A WIRE HAD FRAYED FROM THE LEAD. 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 23492243 ↗
• InjurySep 19, 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 HAD A SURGERY TO REMOVE A GROWTH AT THE LEAD INCISION SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS. THE BIOPSY SHOWED THERE WAS A BACTERIAL INFECTION. THE PATIENT WAS HOSPITALIZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection; Hematoma; Insufficient Information

  MAUDE report 23102124 ↗
• 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 BACTERIAL 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

  MAUDE report 22778455 ↗
• MalfunctionJul 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT¿S LEAD CASING WAS CUT OPEN VERTICALLY AND ONE OF THE WIRES WAS BROKEN. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED, AND NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460746 ↗
• InjuryMay 9, 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 21998842 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE RELATED, THE PATIENT HAS THE COMORBIDITIES OR PRE-EXISTING CONDITIONS THAT THE PHYSICIAN BELIEVES AFFECTED WOUND HEALING AS OBESITY, PRE DIABETIC AND SMOKING, AND THE PHYSICIAN DOES NOT BELIEVE THE WOUND HEALING ISSUE WAS RELATED TO THE NEVRO PROCEDURE, DEVICE, OR THERAPY. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 21690455 ↗
• InjuryMar 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 WAS TREATED WITH ORAL ANTIBIOTICS, AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 21586299 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EPIDURAL HEMATOMA. 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: Hematoma

  MAUDE report 21399559 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STOMACH PAIN AND A NEW UPPER/MID BACK PAIN AT THE LEAD INCISION SITE. THE PHYSICIAN BELIEVES THE ISSUES ARE RELATED TO THE DEVICE. THE PATIENT WAS HOSPITALIZED AND RECEIVED ORAL AND TOPICAL MEDICATION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Abdominal Pain; Pain

  MAUDE report 21200962 ↗
• InjuryJan 6, 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 AT THE LEAD INCISION SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21080996 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTION SUBMITTED TO ADD THAT THE PATIENT WAS HOSPITALIZED, ALSO EXPERIENCED A SEROMA WHICH WAS DRAINED AND WENT BACK INTO SURGERY TO FIX THE SUSPECTED PROLONGED DURAL TEAR. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage; Seroma

  MAUDE report 20474402 ↗
• InjurySep 11, 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 POCKET SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20196113 ↗
• InjuryJul 2, 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 HCP DOES NOT BELIEVE THE INFECTION WAS DEVICE-RELATED. THE PATIENT RECEIVED ORAL ANTIBIOTICS. ALL SYMPTOMS APPEAR TO BE SUBSIDING. NIL FURTHER OOZE FROM SITE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19658560 ↗
• InjuryApr 9, 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 POCKET AND LEADS SITE AND EXPERIENCED SOMETHING WET LIKE FLUID ON HIS BACK. THE PATIENT WAS HOSPITALIZED, UNDERWENT A WASH OUT, RECEIVED ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 19076519 ↗
• InjuryApr 2, 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 AND HAD THE FLUID DRAINED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19029166 ↗
• InjuryMar 7, 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, AS THE SITE APPEARED RED. 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 18856435 ↗
• InjuryMar 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 SITE. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18832735 ↗
• InjuryFeb 28, 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 SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF INFECTION WAS NOT AVAILABLE. PATIENT GOT ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18796394 ↗
• InjuryFeb 16, 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. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS HOSPITALIZED, UNDERWENT A WOUND WASHOUT AND WAS TREATED WITH IV ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18727444 ↗
• InjuryJan 18, 2024Adverse 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 AFTER BEING IMPLANTED. THE DOCTOR DECIDED TO REPLACE THE PADDLE WITH PERC LEADS, AND THE PATIENT REPORTED THE PAIN WAS MUCH MORE MANAGEABLE WITH THE PERC LEADS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 18538727 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT EXPERIENCED A BLOOD CLOT IN THE EPIDURAL SPACE AND REQUIRED EMERGENCY SURGERY TO VACUUM IT OUT. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT IS CURRENTLY PARALYZED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma; Paralysis

  MAUDE report 18365702 ↗