Linear 3-6Recalls & reported problems across all models

We found 4 models of Linear 3-6 by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 366 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2016 and Aug 5, 2026 — classified as 346 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (148 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Linear 3-6 problems

Linear 3-6 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Linear™ 3-6 SC-2366-70

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  202 reports
• Linear™ 3-6 SC-2366-50

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  157 reports
• Linear™ 3-6 SC-2366-30

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  6 reports
• Linear™ 3-6 SC-2366-50E

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 report

Recent Linear 3-6 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026High impedance

  It was reported that the leads had high impedances. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted devices were not returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144368 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION THE LEADS IN ORDER TO ACHIEVE COVERAGE OF A NEWLY IDENTIFIED PAIN AREA. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. POSTOPERATIVELY, THE PATIENT IS RECOVERING AS EXPECTED. THE DEVICE SYSTEM REMAINS IMPLANTED, AND NO COMPONENTS WERE EXPLANTED.

  Patient problems: Pain

  MAUDE report 25622847 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH A SPINAL CORD STIMULATION (SCS) DEVICE UNDERWENT AN EXPLANT PROCEDURE FOR AN UNSPECIFIED REASON. PATIENT POST OPERATIVELY IS DOING GREAT. THE EXPLANTED DEVICES WILL NOT RETURN FOR ANALYSIS AS NO REPRESENTATIVE WAS PRESENT AT THE TIME OF EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671329 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SPINAL CORD STIMULATION (SCS) LEAD INCISION SITE WAS INFECTED. A WOUND DEHISCENCE WAS NOTED. THE PHYSICIAN PERFORMED A WOUND WASH OUT. NOTHING WAS EXPLANTED OR ADDED. THE PATIENT WAS DOING WELL.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 24480046 ↗
• InjuryFeb 10, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD WAS PROTRUDING FROM THE PATIENTS HEAD. THE PATIENT WAS HOSPITALIZED AND UNDERWENT A PROCEDURE IN WHICH A PORTION OF THE LEAD WAS IMMEDIATELY EXPLANTED. A PORTION OF THE LEAD REMAINS IMPLANTED IN THE PATIENT. THE PORTION OF THE LEAD THAT WAS EXPLANTED WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. THE PATIENT HAS NOT BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Erosion; Foreign Body In Patient

  MAUDE report 24309614 ↗
• InjuryJan 9, 2026High impedance; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND DISCOMFORT. IMAGING CONFIRMED THAT THE LEADS MIGRATED, HIGH IMPEDANCES WERE NOTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NOTHING WAS REMOVED OR ADDED.

  Patient problems: Discomfort; Pain

  MAUDE report 24025577 ↗
• InjuryDec 18, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH TWO OF THE FOUR IMPLANTED LEADS WERE EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCE READINGS. IT WAS NOT ABLE TO BE OBTAINED WHICH TWO OF THE FOUR LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843479 ↗
• InjuryNov 13, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED PER HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 23543242 ↗
• InjuryOct 30, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AS ONE OF THE SPINAL CORD STIMULATION (SCS) LEADS WAS NOT AS EFFECTIVE IN HELPING WITH THE PATIENTS PAIN. THE PATIENT ALSO HAD A NEW PAIN IN A DIFFERENT LOCATION AND THEREFORE THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE ONE OF THE IMPLANTED LEADS WAS REMOVED AND TWO NEW LEADS WERE IMPLANTED IN ORDER TO GET BETTER COVERAGE. THE NEW LEAD WAS IMPLANTED CLOSE TO WHERE THE EXPLANTED LEAD WAS BUT SLIGHTLY DIFFERENT AREA SO AS TO COVER THE PAIN AREA. IT IS UNKNOWN WHICH ONE OF THE THREE IMPLANTED LEADS WAS THE ONE THAT WAS REMOVED. POST OPERATIVELY, THE PATIENT WAS DOING WELL. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 23432695 ↗
• InjurySep 19, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING SUFFICIENT RELIEF FROM HER PERIPHERAL NERVE STIMULATION (PNS) LEADS. THE PATIENT UNDERWENT A PROCEDURE WHERE THE PNS LEADS WERE REMOVED AND REPLACED WITH THORACIC SPINAL CORD STIMULATION (SCS) LEADS. POST OPERATIVELY, THE PATIENT WAS SORE BUT RECOVERING AS EXPECTED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Pain

  MAUDE report 23100303 ↗
• InjuryAug 25, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM AND UNDERWENT A LEAD REVISION PROCEDURE IN WHICH ONE LEAD WAS REMOVED, AND TWO NEW LEADS ADDED. IT IS UNKNOWN WHICH OF THE TWO PREVIOUSLY IMPLANTED LEADS WAS EXPLANTED. THE PATIENT IS DOING WELL POST OPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED OF PER HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 22889522 ↗
• InjuryAug 9, 2025High impedance; Off-Label Use; High impedance; Off-Label Use

  IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD AND LEAD EXTENSION REVISION PROCEDURE, WHEREIN TWO LEADS AND TWO LEAD EXTENSIONS WERE EXPLANTED AND REPLACED. THE DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS PROVIDED WITH SEVERAL DISCHARGE OPTIONS FOLLOWING THE PROCEDURE. COVERAGE WAS ACHIEVED IN BOTH UPPER EXTREMITIES, INCLUDING AREAS WITH OVERLAPPING PARESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22767516 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON A SUTURE SITE AT THE SPINAL CORD STIMULATION (SCS) LEAD INSERTION SITE. THE WOUND OF THE LEAD INSERTION SITE HAD NOT CLOSED, AND THE SITE WAS VISIBLY WET. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A PROCEDURE WHERE THE SCS LEAD WAS REMOVED, AND A NEW LEAD WAS IMPLANTED AT A DIFFERENT POSITION. POST OPERATIVELY, THE PATIENT WAS DOING WELL, AND THE PATIENT IS EXPECTED TO FULLY RECOVER. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS CONTAMINATED. THE PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION WAS DEVICE, STIMULATION OR PROCEDURE RELATED. CULTURES WERE NOT TAKEN.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 22652540 ↗
• InjuryJun 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES WERE NOTED ON ONE OF THE TWO LEADS. THE SECOND LEAD WAS ABLE TO COVER THE PATIENTS' PREEXISTING PAIN. THE PATIENT DEVELOPED NEW PAIN AND THE LEAD WITH IMPEDANCES WAS REPLACED TO COVER THE NEW PAIN AREA. PROGRAMMING WAS ATTEMPTED ABUT DID NOT COVER THE NEW PAIN AREA. THE PATIENT IS DOING WELL POST OPERATIVELY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323549 ↗
• InjuryJun 19, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY FROM THE SPINAL CORD STIMULATION (SCS) SYSTEM. HIGH IMPEDANCES WERE DISPLAYED ON THE SCS LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE REPLACED. THE PATIENT WAS RECOVERING AS EXPECTED POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER.

  Patient problems: Pain

  MAUDE report 22294342 ↗

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