Surpass™ LEAD3005-50BRecalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00813426020466), received between Apr 6, 2017 and Sep 24, 2026 — classified as 123 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 133 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection associated with an epidural abscess. The HCP does not believe the infection was device-related. The patient was hospitalized, and the device was subsequently removed. No further complications related to this event have been reported.

  Patient problems: Abscess; Insufficient Information; Unspecified Infection

  MAUDE report 50884856 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE. THE EVENT WAS DETERMINED NOT TO BE DEVICE RELATED. THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS, AND NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25738866 ↗
• InjuryJun 1, 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 ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25352982 ↗
• MalfunctionMay 25, 2026Break

  IT WAS REPORTED THAT THE PATIENT'S LEAD ARE BROKEN AND ARE IMPLANTED IN THE PATIENT, ONLY THE DEVICE WAS EXPLANTED DUE TO MALFUNCTIONING. 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 25271693 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING DEVICE PLACEMENT, THE PATIENT EXPERIENCED NUMBNESS IN THE RIGHT LEG. THE PHYSICIAN DOES NOT THINK THAT THE IMPLANTS ALONE CAUSED ANY ISSUES. THE PHYSICIAN DECIDED TO REMOVE THE ENTIRE SYSTEM. NO FURTHER COMPLICATIONS RELATED TO THIS EVENT HAVE BEEN REPORTED. THE PATIENT REPORTEDLY FEELS WELL FOLLOWING THE PROCEDURE.

  Patient problems: Numbness

  MAUDE report 25260800 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE LEAD WAS PLACED, THE PATIENT EXPERIENCED LOSS OF SENSATION IN THE FEET. THE PHYSICIAN ABORTED THE PROCEDURE, AND THE LEAD WAS REMOVED. FOLLOWING THE PROCEDURE, THE PATIENT APPEARED TO MOVE HER FEET APPROPRIATELY AND WAS REPORTEDLY DOING WELL. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Numbness

  MAUDE report 25150305 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURNING PAIN, SPORADIC ELECTRICAL SHOCKING SENSATIONS, NUMBNESS, AND WEAKNESS IN HIS LOWER EXTREMITIES. THE PATIENT REPORTS SUSTAINING WORSENING NEUROLOGICAL INJURY THE LONGER THE LEADS WERE IMPLANTED THE MORE SEVERE AND PERMANENT THE NERVE DAMAGE BECAME. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE.

  Patient problems: Muscle Weakness/Atrophy; Nerve Damage; Numbness; Pain

  MAUDE report 25086714 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25044695 ↗
• InjuryApr 30, 2026Migration

  IT WAS REPORTED THAT THE PATIENT¿S PADDLE LEAD DID NOT APPEAR TO BE IN AN OPTIMAL MIDLINE POSITION FOLLOWING THE IMPLANT PROCEDURE. UPON ACTIVATION OF THERAPY, THE PATIENT EXPERIENCED SYMPTOMS INCLUDING PAIN, NUMBNESS, DECREASED STRENGTH, AND LOSS OF NERVE FUNCTION, AS WELL AS URINARY CONTINENCE ISSUES REQUIRING REHABILITATION. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED, AND THE PADDLE LEAD WAS REPOSITIONED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Nerve Damage; Numbness; Pain; Urinary Incontinence

  MAUDE report 25043464 ↗
• InjuryFeb 23, 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 WAS HOSPITALIZED, RECEIVED 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 24422695 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE REPORTED ISSUE WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 24129850 ↗
• 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 24109141 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  BASED ON THE INFORMATION RECEIVED, THE PATIENT REQUIRED ONLY A WOUND WASHOUT AND ANTIBIOTIC MEDICATION. NO DEVICE EXPLANATION WAS REPORTED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23644965 ↗
• 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 BACTERIAL INFECTION. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS, THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 23595857 ↗
• InjuryNov 13, 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 HOSPITALIZED AND TREATED WITH BOTH ORAL AND IV ANTIBIOTICS, AND THE DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23542754 ↗
• InjuryNov 11, 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 HAS MULTIPLE LAMINECTOMIES. THE PATIENT WAS HOSPITALIZED AND HAD THE DEVICE EXPLANTED, NOW RECOVERING AT REHABILITATION. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 23527217 ↗
• InjuryOct 22, 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 BECAUSE IT WAS LEAKING. THE PATIENT RECEIVED ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23361126 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE WOUND HEALING. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT RECEIVED ORAL ANTIBIOTICS AND WAS RESUTURED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 23010722 ↗
• InjuryAug 29, 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 THE LEGS FOLLOWING THE PERMANENT IMPLANT. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE ISSUE WAS NOT AVAILABLE. THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE LEAD WAS REPLACED, RESULTING IN AN IMPROVEMENT IN THE CONDITION. THE PATIENT IS CURRENTLY IN A REHABILITATION FACILITY, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22922138 ↗
• InjuryAug 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 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 22788968 ↗
• InjuryJun 27, 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 22350297 ↗
• InjuryJun 12, 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 ONE OF HIS LEGS FOLLOWING THE IMPLANT. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE PADDLE LEAD EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22199319 ↗
• InjuryJun 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 22159969 ↗
• InjuryApr 21, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIB AREA PAIN DUE TO LEAD MIGRATION. 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: Pain

  MAUDE report 21876719 ↗
• InjuryJan 8, 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. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21107594 ↗