SPRINT Extensa, Shipping ConfigurationRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00854001007595), received between May 13, 2021 and Sep 10, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Fracture” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  The patient developed an infection at their lead implant site with a painful lump on their back, accompanied by a fever. The patient presented at the Emergency Department (ED) for evaluation of the issue and was ultimately admitted to the hospital. The patient was prescribed antibiotics, an ultrasound guided needle aspiration was performed to drain fluid from the bump, and their leads were removed prior to the end of treatment.

  Patient problems: Fever; Nodule; Pain; Unspecified Infection

  MAUDE report 50715518 ↗
• InjuryDec 31, 2025Fracture; Fracture

  PATIENT'S LEAD FRACTURED DURING EXPLANT ON (B)(6) 2025. PATIENT REPORTED THAT THEIR LUNG COLLAPSED WHILE THE PHYSICIAN TRIED TO REMOVE THE LEAD REMNANT. THEY REPORTED THAT THE PHYSICIAN TRIED TO GO THROUGH THEIR RIB TO NUMB THE AREA AND PIERCED THEIR LUNG. HE DID AN X-RAY TO LOCATE THE REMNANT BUT DID NOT USE ANY IMAGINING WHILE NUMBING THE AREA. PATIENT WAS RUSHED TO ICU AND STAYED FOR 4 DAYS. PATIENT IS RECOVERED NOW.

  Patient problems: Pneumothorax

  MAUDE report 23935063 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED AN INFECTION AT THEIR LEAD EXIT SITE. LEADS WERE REMOVED AND PATIENT WAS SENT TO THE ED TO BE EVALUATED FOR INFECTION. PATIENT WAS ADMITTED TO THE HOPSITAL AND PRESCRIBED IV AND ORAL ANTIBIOTICS.

  Patient problems: Bacterial Infection; Fluid Discharge; Skin Inflammation/ Irritation

  MAUDE report 22851028 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "PATIENT" DEVELOPED SWELLING AROUND THEIR LEAD EXIT SITES "BEGINNING" THE DAY AFTER LEAD REMOVAL. PATIENT PRESENTED IN THE ER WHERE THEY WERE DIAGNOSED WITH SEPTIC ARTHRITIS. PATIENT UNDERWENT THREE INCISION AND DRAINAGE (I&D) PROCEDURES WHICH INCLUDED SYNOVECTOMY AND USE OF A WOUND VACUUM TO TREAT THE ISSUE. ORAL AND IV ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: Ambulation or Postural Difficulties; Arthritis; Bacterial Infection; Cellulitis; Pain; Swelling/ Edema

  MAUDE report 22382920 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED PAIN AND SWELLING IN ASSOCIATED WITH A SUSPECTED INFECTION. THE PATIENT WAS HOSPITALIZED, THEIR LEAD WAS REMOVED AND THEY WERE PRESCRIBED ANTIBIOTICS AND PAIN MEDICATION.

  Patient problems: Pain; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21336959 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S LEADS WERE REMOVED DUE TO SUSPECTED INFECTION AT MEDIAL LEAD.

  Patient problems: Blister; Erythema; Fluid Discharge

  MAUDE report 19347825 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED IN THE EMERGENCY ROOM FOR AN INFECTION. THE PATIENT'S LEAD WAS REMOVED AND ANTIBIOTICS WERE ADMINISTERED.

  Patient problems: Bacteremia; Bacterial Infection; Unspecified Infection

  MAUDE report 19098494 ↗
• InjuryDec 18, 2023Use of Device Problem; Use of Device Problem

  THE PATIENT STEPPED INTO THE SHOWER WITH THEIR EXTERNAL PULSE GENERATOR STILL RUNNING AND RECEIVED A SHOCK FROM DEVICE. FOR THE FOLLOWING DAYS, SHE WAS UNABLE TO TURN ON THE DEVICE EVEN AT A LOWER SETTING WITHOUT IT BEING PAINFUL. THE PATIENT REACHED OUT TO A FIELD CLINICAL SPECIALIST STATING SHE WAS HAVING PAIN AT THE LEAD EXIT SITE AND AROUND THE BANDAGE. SHE WAS DIRECTED TO FOLLOW-UP WITH HER DOCTOR. SHE SAW HER DOCTOR ON NOVEMBER 20TH WHO SUSPECTED SHE RECEIVED A BURN FROM THE LEADS AND REMOVED THEM. THE DOCTOR DID NOT REPORT AN INFECTION BUT PLACED THE PATIENT ON A 7-DAY COURSE OF ANTIBIOTICS AS A PRECAUTION.

  Patient problems: Burn(s); Erythema; Neck Pain; Pain; Shock from Patient Lead(s)

  MAUDE report 18346905 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERGOING DUAL LEAD PLACEMENTS TARGETING THE FEMORAL NERVE(S) EXPERIENCED SLURRED/STUTTERING SPEECH, AND GROSS MOTOR CONTRACTIONS THROUGH THE ABDOMEN/SHOULDERS DURING TESTING TO TARGET PLACEMENT OF THEIR SECOND LEAD. THE SYSTEM WAS SUBSEQUENTLY REMOVED, INCLUDING THE FIRST LEAD THAT THE PATIENT RECEIVED, PRIOR TO CONCLUDING THE PLACEMENT PROCEDURE AND THE NURSING TEAM ATTENDED TO THE PATIENT'S HEALTH AT THAT TIME.

  Patient problems: Convulsion/Seizure

  MAUDE report 18319335 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CHECKED INTO THE HOSPITAL WITH A FEVER OF 102.5, CHILLS TO THE POINT OF SHAKING, DISORIENTATION, AND TENDERNESS AT THE SPRINT LEAD EXIT SITES IN HIS BACK. THE EXAMINING PHYSICIAN REPORTEDLY NOTED REDNESS IN THE AREA OF THE LEAD EXIT SITES AND SUSPECTED MRSA. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS WHILE ADMITTED AND ORAL ANTIBIOTICS FOR USE AFTER DISCHARGE. HE WAS DISCHARGED FROM THE HOSPITAL AFTER 5 DAYS AND WAS NOT ABLE TO VERIFY THAT USING THE SPRINT DEVICE IS WHAT CAUSED HIS ADVERSE EVENTS.

  Patient problems: Confusion/ Disorientation; Fever; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 18318665 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED SORENESS IN THE MUSCLE BENEATH THEIR LEAD EXIT SITES, AS WELL AS TENDERNESS AND SWELLING. THE PATIENT PRESENTED IN-CLINIC THE FOLLOWING DAY WITH SEROSANGUINOUS DRAINAGE ON THEIR BANDAGE AND ERYTHEMA AROUND THE LEAD EXIT SITE. ADDITIONALLY, THE PATIENT REPORTED THAT THEY HAD A FEVER OF 100.4 THE PREVIOUS NIGHT. THE PATIENT WAS DIAGNOSED WITH AN INFECTION, PRESCRIBED ANTIBIOTICS, AND THEIR LEADS WERE REMOVED PRIOR TO THE PLANNED END OF TREATMENT DATE.

  Patient problems: Fever; Fluid Discharge; Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 18181069 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS SUSPECTED INFECTION.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 17868551 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SEEN AT THE EMERGENCY ROOM AND REPORTED EXPERIENCING INCREASED KNEE PAIN APPROXIMATELY 40 DAYS INTO TREATMENT. THE PATIENT BECAME DISORIENTED AND BEDRIDDEN IN THE FOLLOWING DAYS. PHOTOS WERE PROVIDED AND APPEAR TO SHOW SWELLING OF THE KNEE, AS WELL AS AREAS OF REDNESS AND FLAKING SKIN AT BOTH LEAD EXIT SITES. THE PATIENT WAS HOSPITALIZED AND HAD THEIR LEADS REMOVED. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHILE HOSPITALIZED TO CLEAN INFECTION FROM THEIR KNEE.

  Patient problems: Confusion/ Disorientation; Inflammation; Sepsis; Skin Inflammation/ Irritation

  MAUDE report 17868194 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), THE PATIENT STATED THEIR LEAD EXIT SITE WAS RED AND HAD CLEAR LIQUID DRAINAGE. THEY APPLIED TRIPLE ANTIBIOTIC CREAM, ANTIFUNGAL CREAM, AND THEN DESCRIBED USING CAVILON WIPES ON THE LEAD EXIT SITE AS WELL. THEY WERE INFORMED THAT IS NOT THE INTENDED USE OF THE CAVILON WIPES AND THAT THEY SHOULD FOLLOW-UP WITH THE PHYSICIAN. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THEN AROUND (B)(6) THE PATIENT STARTED TO EXPERIENCE SWELLING IN THEIR CALF AND PULLED THE LEADS OUT THEMSELVES. THEY WENT TO THE EMERGENCY ROOM ON (B)(6) FOR THE SWELLING AND A FEW DAYS LATER THE PATIENT'S PCP STARTED THEM ON ANOTHER ANTIBIOTIC. THEY RETURNED TO THE EMERGENCY ROOM ON (B)(6) FOR SWELLING, REDNESS, PAIN, AND CONCERNS OF A BLOOD CLOT. X-RAYS DETERMINED THERE WAS NO LEAD REMANENT. THEY WERE HOSPITALIZED FROM (B)(6), THEY RECEIVED IV ANTIBIOTICS, AND THEY DID "IRRIGATION PROCEDURES" TO DRAIN THE LEG. THEY DID A CULTURE, AND THEY WERE PUT ON A DIFFERENT ANTIBIOTIC. THEY WILL BE ON ANTIBIOTICS FOR THE NEXT 6 WEEKS VIA A PIC LINE.

  Patient problems: Skin Inflammation/ Irritation; Swelling/ Edema; Unspecified Infection

  MAUDE report 17482368 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING A COLLAPSED LUNG (I.E., PNEUMOTHORAX) DURING THEIR LEAD PLACEMENT PROCEDURE. PER THE COMPLAINT REPORT, THE PATIENT'S BREATHING BECAME SHORT AND SHALLOW AFTER RETURNING HOME FROM THE PROCEDURE AND THIS PERSISTED FOR FIVE DAYS BEFORE WORSENING. AFTER CONSULTING HER PULMONOLOGIST ON THE FOLLOWING DAY, THE PATIENT WAS ADVISED TO VISIT THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED FOR APPROXIMATELY NINE DAYS. THE PATIENT REPORTED THAT SHE WAS DIAGNOSED WITH ACUTE RESPIRATORY FAILURE AND PNEUMOTHORAX ON THE SAME SIDE AS HER STIMULATION DEVICE THAT WAS TREATED BY ADMINISTERING HIGH LEVELS OF OXYGEN AND CORTICOSTEROIDS (I.E., PREDNISONE).

  Patient problems: Pneumothorax; Respiratory Failure

  MAUDE report 17458643 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT REPORTS THAT THE PATIENT EXPERIENCED REDNESS SURROUNDING THEIR LEAD EXIT SITES BEGINNING 12 DAYS AFTER THE LEADS WERE IMPLANTED, AS WELL AS SEROUS FLUID DRAINAGE FROM THE EXIT SITES BEGINNING APPROXIMATELY ONE MONTH AFTER THE LEADS WERE IMPLANTED. THE PATIENT WAS PRESCRIBED BACTRIM FOR TREATMENT OF THE ISSUE.

  Patient problems: Erythema; Fluid Discharge; Skin Infection

  MAUDE report 17045742 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PUS, REDNESS, AND PAIN AT THE LEAD EXIT SITE DURING A BANDAGE CHANGE. A PHOTO WAS PROVIDED SHOWING SEVERE REDNESS (ERYTHEMA) AND AREAS OF RAISED SKIN (BUMPS) THAT APPEAR TO HAVE FORMED A RASH SURROUNDING ONE OF THE LEAD EXIT SITES, APPROXIMATING THE SHAPE OF THE NON-ADHESIVE PORTION OF THE BANDAGE THAT WOULD HAVE BEEN PLACED ON TOP OF IT. THE PHOTO ADDITIONALLY SHOWS A DARKER AREA OF DISCOLORATION SURROUNDING THE LEAD EXIT SITE, WHICH MAY BE ATTRIBUTED TO THE HARDENED SURGICAL GLUE WHICH THE PATIENT'S PHYSICIAN REPORTEDLY LIBERALLY APPLIED. THE PATIENT WENT TO URGENT CARE FOR EXAMINATION OF THE ISSUE, WHERE A NURSE REPORTEDLY SUSPECTED THAT THE ISSUE WAS THE RESULT OF AN INFECTION. NOTE THAT THERE WAS NO REPORT OF A CULTURE TO TEST FOR INFECTION. THE PATIENT WAS REPORTEDLY PRESCRIBED ANTIBIOTICS AT THE TIME OF THE URGENT CARE VISIT FOR TREATMENT OF THE ISSUE.

  Patient problems: Erythema; Purulent Discharge; Skin Infection

  MAUDE report 17023549 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED REGIONAL SALES MANAGER (RSM) WANTING TO HAVE HER LEADS REMOVED. PATIENT STATED THAT SHE FELT LIKE SHE HAD A INFECTION. PATIENT MADE AN APPOINTMENT TO SEE HER DOCTOR AND THE RSM MET WITH THEM. THE DECISION WAS MADE TO PULL THE LEAD. THERE WAS NO VISIBLE INFECTION BUT THE DOCTOR MADE THE DECISION BECAUSE THE AREA WHERE THE LEAD WAS FELT " HARD" AND THE PATIENT WAS CLOSE TO THE END OF THERAPY. THE RSM GOT A CALL FROM THE DOCTOR THAT THE PATIENT WAS GOING TO BE ADMITTED AND HAVE SURGERY TO REMOVE THE "INFECTED AREA " PER THE DOCTOR. PATIENT IS IN THE HOSPITAL WITH A DRAIN. PER RSM, THERE WAS NO SIGN OF INFECTION ON A SURFACE LEVEL WHERE THE LEAD WAS INSERTED BUT UNDERNEATH THE SKIN THERE WAS A INFECTION.

  Patient problems: Abscess; Subcutaneous Nodule; Unspecified Infection

  MAUDE report 14112362 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT THAT WAS TREATED FOR LOWER BACK PAIN USING THE SPRINT PNS SYSTEM HAD HIS PERCUTANEOUS LEADS REMOVED ON (B)(6) 2021 ACCORDING TO PLAN (THE LEADS ARE ONLY INTENDED TO BE IMPLANTED FOR 60 DAYS). THE PHYSICIAN SAID THE LEADS APPEARED INTACT AFTER REMOVAL AND THE PATIENT HAD 50% IMPROVEMENT IN PAIN. ON (B)(6) 2021 THE PATIENT CONTACTED THE DOCTOR TO REPORT 2 GOLF BALL SIZED HEMATOMAS AT THE LEAD SITES. THE PATIENT WAS INSTRUCTED TO APPLY ICE. THE PATIENT CONTACTED THE DOCTOR ON (B)(6) 2021 TO REPORT THAT THE HEMATOMAS HAD SHRUNK CONSIDERABLY, BUT THAT THE BACK PAIN WAS SEVERE AND HE HAD TROUBLE WALKING. PATIENT ALSO REPORTED NUMBNESS AND TINGLING IN HIS FEET. WE WERE LATER NOTIFIED THAT THE SWELLING IMPROVED, BUT THE PATIENT HAS COMPLETE DROP FOOT ON RIGHT SIDE. ON (B)(6) 2021 WE LEARNED THAT THE DROP FOOT WAS NOT A PREEXISTING CONDITION. LABS RULED OUT INFECTION. MRI WAS NOT AS CONCLUSIVE, COULD BE OSTEOMYELITIS OR DEGENERATIVE CHANGES. FOOT DROP IS UNRESOLVED.

  Patient problems: Ambulation or Postural Difficulties; Hematoma; Muscle Weakness/Atrophy; Numbness

  MAUDE report 12583988 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD HIS ORIGINAL TOTAL KNEE ARTHROPLASTY SURGERY (B)(6) 2020, FOLLOWED BY CONSTANT PAIN THAT FELT LIKE "SOMEONE RUBBING SOMETHING AGAINST A SEVERE SUNBURN". SPRINT LEADS WERE IMPLANTED ON (B)(6) 2021, AND PLACEMENT WAS CONFIRMED BY IMPLANTING PHYSICIAN TO BE 1CM FROM GENICULAR NERVE. PATIENT COMPLAINED OF SEVERE PAIN IN HIS KNEE AND BELOW. ON (B)(6) 2021, AREA WAS RED, VERY HOT, AND FELT LIKE A RUBBER-BAND WAS AROUND IT AND IT WAS GOING TO SNAP OFF. PATIENT SAW IMPLANTING PHYSICIAN WHO PULLED THE LEADS WHICH WERE INTACT UPON REMOVAL AND STARTED PATIENT ON ANTIBIOTICS. ON (B)(6) 2021 PAIN CONTINUED AND PATIENT WENT TO THE EMERGENCY DEPARTMENT, ED TOOK X-RAYS AND WITHDREW FLUID FROM THE JOINT SPACE AND CONFIRMED AN INFECTION. CHANGED TYPE OF ANTIBIOTICS PATIENT WAS TAKING. PATIENT FOLLOWED UP WITH ORTHOPEDIC SURGEON WHO TOOK PATIENT TO SURGERY (DATES UNKNOWN) AND CLEANED OUT "JOINT AND PADS" AS IMPLANTED PADS WERE INFECTED. 8 DAYS LATER PATIENT WENT TO SURGERY AGAIN AND JOINT AND PADS WERE CLEANED AGAIN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11916229 ↗
• InjuryMay 13, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PATIENT HAD A COMPLICATION AND DEVICE PLACEMENT COULDN'T BE COMPLETED. DURING PLACEMENT OF THE STIMULATING PROBE NEAR THE INTERCOSTAL NERVE AT THE T9 LEVEL, THE PATIENT EXPERIENCED VASOVAGAL SYNCOPE. HE WAS MOVED OFF THE TABLE AND INTO POST-OP TO GET HIS VITALS UNDER CONTROL. A CHEST X-RAY SHOWED A PNEUMOTHORAX AND HE WAS MOVED TO THE ER FOR A CHEST TUBE. THE PATIENT WAS STABILIZED, KEPT FOR OBSERVATION OVERNIGHT, AND WAS RELEASED WITH NO FURTHER COMPLICATION AND NO KNOWN LASTING EFFECTS.

  Patient problems: Pneumothorax

  MAUDE report 11821785 ↗