Linear™ 3-6 SC-2366-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729789659), received between Dec 15, 2016 and May 16, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2023Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTERMITTENT PINCHING SENSATION IN THE RIGHT LOWER BACK WHEN THE STIMULATION WAS ON. MIGRATION OF THE RIGHT CLUNEAL LEAD WAS CONFIRMED WITH IMAGING, AND DETERMINED TO BE THE CAUSE OF THE PATIENTS' SYMPTOMS. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH BOTH LEADS WERE REPLACED, AND IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 16943675 ↗
• InjuryJun 25, 2021High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PHYSICIAN ASSESSED THE EVENT WAS DUE TO HIGH IMPEDANCES CAUSE BY SCAR TISSUE THAT HAD FORMED AROUND SEVERAL OF THE LEAD CONTACTS. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL, AND THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE ALL IMPLANTED DEVICES AND WILL BE IMPLANTED AGAIN AT A LATER DATE. PATIENT WAS STABLE POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief; Scar Tissue

  MAUDE report 12071141 ↗
• InjuryJan 27, 2021High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE A LEAD WITH HIGH IMPEDANCES WHEREIN CAUSING THE PATIENT TO EXPERIENCE INADEQUATE STIMULATION. FOLLOWING THE PROCEDURE THE PATIENT WAS NOTED TO BE DOING WELL AND FULLY RECOVERED.

  Patient problems: No Code Available

  MAUDE report 11240246 ↗
• MalfunctionOct 11, 2017High impedance; High impedance

  A REPORT WAS RECEIVED THAT THREE OF THE FOUR LEADS IMPLANTED IN THE PATIENT DISPLAYED HIGH IMPEDANCE READINGS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN ALL OF THE LEADS AND LEAD SPLITTERS WERE REPLACED. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT IS DOING WELL POST-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6942915 ↗
• MalfunctionDec 29, 2016High impedance; High impedance

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION ON THEIR RIGHT SIDE DUE TO HIGH IMPEDANCES WHICH WERE DISPLAYED ON BOTH LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN BOTH LEADS WERE REPLACED. DEVICE MALFUNCTION WAS SUSPECTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 6214146 ↗
• InjuryDec 15, 2016Fracture; Fracture

  A REPORT WAS RECEIVED THAT FOLLOWING AN EXPLANT PROCEDURE, THE DEVICE ANALYSIS REVEALED THE LEAD WAS FRACTURED AT THE DISTAL ELECTRODE ARRAY. THERE WERE NO ABNORMALITIES DETECTED ON THE LEAD PRIOR TO THE EXPLANT PROCEDURE. IT IS UNKNOWN WHAT CAUSED THE FRACTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6176669 ↗

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-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-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-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-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-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-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-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.