Linear™ 3-6 SC-2366-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 08714729789567), received between Dec 13, 2016 and Aug 5, 2026 — classified as 192 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (73 reports).

17 other recalls cover devices cleared under the same FDA submission (P030017); they may or may not involve this specific model.

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 202 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE LEAD WAS POKING THROUGH THE PATIENT'S SKIN AND THE WIRES WERE EXPOSED. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD TURNED SIDEWAYS IN THE POCKET. THE PHYSICIAN OPTED TO REMOVE THE SPINAL CORD STIMULATOR (SCS) SYSTEM DUE TO RISK OF INFECTION. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

  Patient problems: Erosion

  MAUDE report 21998201 ↗
• InjuryApr 18, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DUE TO HIGH IMPEDANCES ON THE RIGHT OCCIPITAL LEAD. PROGRAM OPTIMIZATION WAS ATTEMPTED AND WAS NOT SUCCESSFUL. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS KEPT BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 21867829 ↗
• InjuryMar 3, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE THERAPY DUE TO LEAD MIGRATION, AS CONFIRMED BY IMAGING. CONSEQUENTLY, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE TWO OF THE SEVEN IMPLANTED LEADS WERE REPOSITIONED. THE PATIENT WAS RECOVERING AS EXPECTED. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: Pain

  MAUDE report 21510850 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DUE TO AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD REVISION WAS DUE TO A TENSION LOOP THAT WAS BOTHERSOME FOR THE PATIENT AND THE PHYSICIAN RELEASED THAT LOOP.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381867 ↗
• InjuryFeb 6, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT WHEN THE PATIENT FLEXED HIS HEAD BACKWARD, THE DISTAL PORTION OF THE BACK/OCCIPITAL LEFT LEAD WOULD POKE OUT. ADDITIONALLY, THE PATIENT WAS EXPERIENCING SOME MOTOR STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE PULLED BACK. THE PATIENT WAS DOING WELL. THE LEADS REMAIN IMPLANTED IN THE PATIENT AND IN USE.

  Patient problems: Erosion

  MAUDE report 21320836 ↗
• InjuryJan 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDESIRED MOTOR STIMULATION. THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE. THE DEVICES REMAIN IMPLANTED AND IN SERVICE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 21075515 ↗
• InjuryDec 29, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION THERAPY. IMAGING DURING THE SUBSEQUENT EXPLANT PROCEDURE REVEALED LEAD MIGRATION, CONFIRMING THE CAUSE OF THE INADEQUATE THERAPY PER THE PHYSICIAN. THE DEVICES WERE EXPLANTED, AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THE MEDICAL FACILITY RETAINED THEM.

  Patient problems: Pain

  MAUDE report 21032570 ↗
• InjuryDec 6, 2024High impedance; Unexpected Therapeutic Results; Migration; High impedance; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM LEADS AFTER HAVING USED A NECK AND BACK MASSAGER. A REVIEW OF THE SYSTEM FOUND THAT HIGH IMPEDANCES WERE NOTED ON ONE OF THE CONTACTS, AND LEAD MIGRATION WAS CONFIRMED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE DEVICES WERE EXPLANTED AND IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE NOT RELEASED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 20861725 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO LEADS ERODING THROUGH THE SKIN. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Erosion

  MAUDE report 20805993 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE RIGHT DELTOID INCISION SITE. NO KNOWN SYMPTOM WAS REPORTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) LEAD EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED.

  Patient problems: Unspecified Infection

  MAUDE report 20772240 ↗
• InjuryOct 3, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT FELL ASLEEP ON A PLANE WITHOUT THEIR NECK PILLOW WHICH CAUSED THE SPINAL CORD STIMULATION (SCS) LEAD TO MIGRATE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD WAS REMOVED AND REPLACED WITH A NEW ONE. POST OPERATIVELY, THE PATIENT WAS RECOVERING WITHOUT COMPLICATIONS. THE LEAD WILL NOT BE RETURNED AS IT WAS RETAINED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364155 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPOSED ELECTRODE AND DEVELOPED INFECTION BEHIND THE EAR, OVER THE SPINAL CORD STIMULATION (SCS) LEAD. SYMPTOMS WERE SWELLING, INFLAMMATION AND REDNESS. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED PER FACILITY PREFERENCE.

  Patient problems: Bacterial Infection; Erosion; Erythema; Inflammation; Swelling/ Edema

  MAUDE report 20312308 ↗
• InjurySep 10, 2024High impedance; Migration; High impedance; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MOTOR VEHICLE ACCIDENT AND SUBSEQUENTLY THE SPINAL CORD STIMULATION (SCS) LEADS MIGRATED. IN ADDITION, ONE OF THE PATIENTS LEADS DISPLAYED HIGH IMPEDANCES, ALTHOUGH IT IS UNCERTAIN WHEN THIS IMPEDANCE FIRST PRESENTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE REPOSITIONED. NO DEVICES WERE IMPLANTED OR EXPLANTED. IT WAS NOTED THAT POSTOPERATIVELY THE HIGH IMPEDANCES REMAINED, AND IT IS UNCERTAIN IF IT IMPACTED THE PATIENTS THERAPY. NO FURTHER INFORMATION CAN BE OBTAINED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185961 ↗
• InjuryAug 9, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT IS REPORTED THAT THE PATIENTS' LEAD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM MIGRATED CAUSING THE PATIENT TO EXPERIENCE INADEQUATE STIMULATION. IMAGING WAS PERFORMED WHICH CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH ONE OF THE FOUR IMPLANTED LEADS WAS EXPLANTED AND REPLACED WITH A NEW LEAD, AND TWO OF THE LEADS WERE REPOSITIONED. THE PATIENT IS DOING WELL POST OPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE FACILITY, AND THE REMAINING DEVICES REMAIN IMPLANTED AND IN SERVICE.

  Patient problems: Pain

  MAUDE report 19953110 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DISTAL END OF THE LEAD WAS POKING, NOT QUITE OUT OF SKIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS PULLED BACK AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Erosion

  MAUDE report 19925188 ↗
• InjuryJul 14, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNDESIRED AND INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL WITH GOOD COVERAGE POSTOPERATIVELY.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 19737159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017. One submission often covers many models, so check the product and lot details in each record.

• Z-2879-2026 · Jun 17, 2026 · Open, Classified
  INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spin
• Z-2404-2026 · Apr 29, 2026 · Open, Classified
  Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
• Z-2617-2024 · Jul 17, 2024 · Open, Classified
  WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
• Z-2120-2020 · Apr 24, 2019 · Terminated
  Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Devic
• Z-2124-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Gene
• Z-2119-2020 · Apr 24, 2019 · Terminated
  ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left
• Z-2121-2020 · Apr 24, 2019 · Terminated
  LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electric
• Z-2122-2020 · Apr 24, 2019 · Terminated
  The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic i
• Z-2123-2020 · Apr 24, 2019 · Terminated
  Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in
• Z-1409-2010 · Mar 19, 2010 · Terminated
  Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
• Z-0271-2009 · Sep 22, 2008 · Terminated
  Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Po
• Z-1441-2012 · Apr 22, 2008 · Terminated
  OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractabl
• Z-0960-2008 · Oct 5, 2007 · Terminated
  Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
• Z-0055-2008 · Aug 3, 2007 · Terminated
  Precision Implantable Pulse Generator (IPG), Model Number SC-110
• Z-0700-2007 · Jan 30, 2007 · Terminated
  The Precision Implantable Pulse Generator, Model Number SC-1110

…and 2 more.