SPRINT Endura, Sales ConfigurationRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00854001007540), received between Mar 14, 2023 and Oct 24, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED ALLERGIC REACTION REQUIRING EMERGENCY DEPARTMENT PROVIDER TO REMOVE LEAD.

  Patient problems: Fatigue; Hypersensitivity/Allergic reaction; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 20523903 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED A SPIKE IN THEIR BLOOD PRESSURE AND THEIR LEADS WERE SUBSEQUENTLY REMOVED FIVE DAYS AFTER LEAD PLACEMENT.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 18110234 ↗
• InjuryApr 7, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A SINGLE LEAD WAS PLACED ON (B)(6) 2023, TARGETING THE RIGHT SIDE AT L5 MEDIAL BRANCH OF THE DORSAL RAMUS. THE PATIENT REPORTED THAT SHE HAD DIFFICULTY WALKING THAT STARTED AFTER SHE RETURNED HOME FROM THE PROCEDURE. ON (B)(6) 23, THE PATIENT CONTACTED THE IMPLANTING PHYSICIAN AND REPORTED THAT SHE CANNOT WALK, AND HER BASELINE PAIN IS NOW RADIATING TO THE LEFT SIDE. THE PATIENT WAS ALSO EXPERIENCING SOME URINARY RETENTION, NOTING ONLY DRIBBLING, NOT A STRONG STREAM.

  Patient problems: Limb Pain; Paralysis; Paresis; Urinary Retention

  MAUDE report 16702699 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CONTACTED THEIR IMPLANTING PHYSICIAN REGARDING A CONCERN FOR INFECTION AND SENT THEM A PHOTO OF THE AFFECTED AREA. A PHOTO ATTACHED TO THE COMPLAINT APPEARS TO SHOW REDNESS SURROUNDING THE LEAD EXIT SITE, AS WELL AS SIGNS OF POSSIBLE SKIN IRRITATION EXTENDING TO THE EDGES OF THE NON-ADHESIVE PORTION OF THEIR BANDAGE. THE PHOTO ADDITIONALLY APPEARS TO SHOW WHAT MAY BE EITHER DISCHARGE OR DRIED SURGICAL GLUE AT THE LEAD EXIT SITE AND ON THE LEAD ADJACENT TO THE EXIT SITE. THE PATIENT REPORTEDLY PROCEEDED TO THE EMERGENCY ROOM FOR EVALUATION OF THE ISSUE. THE PATIENT'S LEAD WAS REMOVED ON THE SAME DAY THEY WENT TO THE EMERGENCY ROOM. THE PATIENT WAS PRESCRIBED TWO TYPES OF ANTIBIOTICS FOR TREATMENT OF THE ISSUE AND THE ISSUE DID NOT REQUIRE THE PATIENT TO BE HOSPITALIZED, PER FEEDBACK FROM REPRESENTATIVES IN CONTACT WITH THE PATIENT.

  Patient problems: Bacterial Infection; Nodule; Purulent Discharge; Skin Inflammation/ Irritation

  MAUDE report 16682814 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING POST-PROCEDURE PATIENT EDUCATION, THE PATIENT STATED HER HEAD FELT FUNNY AND SHE BECAME VERY PALE. THE CLINIC STAFF TRANSFERRED HER TO A STRETCHER (LYING FLAT) AND SHE HAD MULTIPLE SEIZURES BEFORE BEING TRANSFERRED VIA EMS TO THE HOSPITAL. PATIENT'S SEIZURES CORRELATED WITH POSITIONAL CHANGES (I.E., SITTING UP, TRANSFER FROM STRETCHER TO STRETCHER). THE PATIENT WAS SEDATED VIA EMS PRIOR TO LEAVING THE CLINIC. STIMULATION WAS ONLY ADMINISTERED DURING TESTING IN THE LEAD PLACEMENT PROCEDURE AND THERE WERE NO ISSUES INTRAOPERATIVELY. STIMULATION WAS NEVER TURNED ON IN RECOVERY AND THE EXTERNAL PULSE GENERATOR WAS REMOVED FROM HER BODY PRIOR TO TRANSFER. THE PATIENT'S DAUGHTER REPORTED THAT THE PATIENT HAS HAD SEIZURES PREVIOUSLY WHEN HAVING PROCEDURES AT THE HOSPITAL. THE PATIENT WAS DISCHARGED THAT SAME EVENING AND HAD ANOTHER SEIZURE THE NEXT MORNING.

  Patient problems: Convulsion/Seizure

  MAUDE report 16590497 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LEAD WAS PLACED WITHOUT DIFFICULTY AND THEN THE PATIENT EXPERIENCED A VASOVAGAL EPISODE DURING THE SUBSEQUENT TESTING OF THE LEAD. THE PATIENT THEN DEVELOPED BRADYCARDIA AND LOW BLOOD PRESSURE. THE DOCTOR ADMINISTERED GLYCOPYRROLATE 0.1 MG AND EPHEDRINE 10 MG INTRAVENOUSLY WHICH STABILIZED BOTH THE PATIENT'S HEART RATE AND BLOOD PRESSURE TO HER NORMAL VALUES. THE PATIENT WAS IN VERBAL COMMUNICATION WITH THE INVESTIGATOR THROUGHOUT AND NEVER LOST CONSCIOUSNESS. THE PATIENT STATED THAT SHE FREQUENTLY HAS THESE VASOVAGAL EPISODES AND THIS EXPERIENCE WAS THE SAME AS PREVIOUS EPISODES.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Presyncope

  MAUDE report 16539328 ↗