SPRINT Extensa, Sales ConfigurationRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00854001007557), received between Feb 15, 2023 and Apr 12, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2023Off-Label Use; Off-Label Use

  PATIENT HAD AN INFECTION AT THE TIME OF LEAD EXPLANT ON (B)(6) 2023. THE DEVICE WAS IMPLANTED FOR MUCH LONGER THAN THE 60 DAYS INDICATED IN THE INSTRUCTIONS FOR USE. THE DOCTOR PRESCRIBED ANTIBIOTICS AND MRI IMAGING. THE PATIENT WAS DIAGNOSED WITH A STAPH INFECTION. THE MRI SHOWED THE INFECTION DID NOT REACH SPINAL CORD, BUT SHOWED INFLAMMATION OF HIPS, BOTTOM, AND LEGS.

  Patient problems: Bacterial Infection; Purulent Discharge; Skin Infection

  MAUDE report 16724370 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING PAIN BEHIND THEIR KNEE AND FLUID DRAINAGE FROM THEIR LEAD EXIT SITES BEGINNING TWO DAYS AFTER THE LEADS WERE PLACED. PER FOLLOW-UP WITH A REPRESENTATIVE IN CONTACT WITH THE PATIENT, THE PATIENT REPORTED SEVERE PAIN, REDNESS, SWELLING, CONTINUED DRAINAGE, AND THE INABILITY TO BEND THEIR LEG/WALK THE FOLLOWING DAY (I.E., 3 DAYS AFTER LEAD PLACEMENT) AND WENT TO THE EMERGENCY ROOM FOR EVALUATION. A PHOTO WAS PROVIDED THAT APPEARS TO SHOW THE BANDAGE PARTIALLY SATURATED WITH BROWN-TINTED FLUID, AS WELL AS REDNESS OF THE SKIN SURROUNDING BOTH OF THE LEAD EXIT SITES AND EXTENDING PAST THE EDGE OF THE BANDAGE. BOTH OF THE PATIENT'S LEADS WERE REPORTEDLY REMOVED INTACT AT THE EMERGENCY ROOM. THE PATIENT WAS REPORTEDLY STARTED ON TWO TYPES OF IV ANTIBIOTICS (TYPE, FREQUENCY, AND DOSAGE UNKNOWN) AND ADMITTED TO THE HOSPITAL. THE PATIENT REPORTED EXPERIENCING CONTINUED AND INCREASED SWELLING AND REDNESS OF THE AFFECTED AREA FOR AT LEAST TWO OF THE FOLLOWING DAYS; PHOTOS WERE PROVIDED THAT APPEAR TO SHOW DATED BOUNDARY LINES ON THE PATIENT'S LEG INDICATING THE SPREAD OF REDNESS IN THE DAYS FOLLOWING THE PATIENT'S ADMISSION TO THE HOSPITAL. A CT WITH CONTRAST W

  Patient problems: Ambulation or Postural Difficulties; Cellulitis; Fluid Discharge; Inflammation

  MAUDE report 16582140 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE REPORT, THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP 19 DAYS AFTER LEAD PLACEMENT WITH SLIGHT REDNESS AT HIS RIGHT LEAD EXIT SITE AND EVIDENCE OF DRAINAGE COVERING THE PAD OF HIS TEGADERM BANDAGE AND SLIGHT SKIN IRRITATION (I.E., REDNESS) AROUND BOTH OF THE LEAD EXIT SITES, AS WELL AS WHAT APPEARS TO BE DRIED SURGICAL GLUE ON THE LEAD AWAY FROM THE EXIT SITE. THE PATIENT'S PHYSICIAN VISUALLY ASSESSED THE ISSUE AND ELECTED TO NOT PRESCRIBE ANTIBIOTICS AT THAT TIME, AND THE PATIENT'S CARETAKER WAS INSTRUCTED TO FOLLOW-UP IF REDNESS OR DRAINAGE PERSISTED. APPROXIMATELY THREE DAYS AFTER BEING SEEN IN CLINIC THE PATIENT BEGAN EXPERIENCING SIGNIFICANT SORENESS IN HIS KNEE AND THE BANDAGE BECAME SATURATED WITH DRAINAGE OVERNIGHT. THE PATIENT SOUGHT MEDICAL ATTENTION AT AN URGENT CARE. THE PATIENT WAS THEN DIRECTED FROM URGENT CARE TO AN EMERGENCY ROOM, WHERE A PHYSICIAN DIAGNOSED HIM WITH SEPSIS OF THE KNEE. A TEST FOR MRSA WAS PERFORMED AND IS CURRENTLY PENDING RESULTS. THE PATIENT WAS HOSPITALIZED, AND THE FOLLOWING DAY UNDERWENT A SURGICAL DEBRIDEMENT PROCEDURE FOR HIS KNEE DURING WHICH THE SURGEON WAS UNABLE TO LOCATE THE PATIENT'S LEADS. A PHOTO ATTACHED TO THE COMPLAINT FRO

  Patient problems: Inflammation; Sepsis; Skin Inflammation/ Irritation

  MAUDE report 16477465 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD HER PERCUTANEOUS LEADS REMOVED APPROXIMATELY 3 WEEKS FOLLOWING THEIR PLACEMENT DUE TO CELLULITIS. THE PATIENT REPORTEDLY PRESENTED AT THE EMERGENCY ROOM WITH A HIGH FEVER, AND SAW HER IMPLANTING PHYSICIAN FOR FOLLOW-UP THE NEXT DAY. PER THE REPORT, A POCKET OF FLUID WAS NOTED AT THE EXIT SITE DURING THE FOLLOW-UP APPOINTMENT AND THE PATIENT EXPERIENCED SIGNIFICANT DRAINAGE AFTER THE LEADS WERE REMOVED. THE PATIENT WAS REPORTEDLY PRESCRIBED ANTIBIOTICS (AZITHROMYCIN) FOR TREATMENT OF THE ISSUE FOLLOWING THE REMOVAL OF THE LEADS.

  Patient problems: Cellulitis; Fever; Fluid Discharge

  MAUDE report 16379949 ↗