Avista™ MRI SC-2408-74Recalls & reported problems

Summary

The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 08714729904823), received between Dec 7, 2016 and Jul 27, 2026 — classified as 128 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Migration” (56 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026High impedance

  It was reported that the leads had high impedances. The patient underwent a lead replacement procedure. Patient for coverage of pain area in recovery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037763 ↗
• InjuryFeb 6, 2026High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) LEAD DISPLAYED HIGH IMPEDANCES AND WAS AFFECTING STIMULATION. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD WAS REMOVED AND REPLACED. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24284364 ↗
• InjuryJan 23, 2026Charging Problem; Migration

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED DUE TO MIGRATION AND CHARGING DIFFICULTIES, RESPECTIVELY. ELECTROCAUTERY WAS USED. THE IPG AND LEADS WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163663 ↗
• InjuryJan 15, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE THERAPY. IMAGING IDENTIFIED THAT THE LEAD MIGRATED FROM THE T10 TO THE T12 VERTEBRAE AND WAS NO LONGER ABLE TO DELIVER APPROPRIATE THERAPY. THEREFORE, THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. THE DEVICE SERIAL NUMBER AND ORIGINAL IMPLANT DATE ARE UNKNOWN AND CANNOT BE OBTAINED DESPITE GOOD FAITH EFFORT.

  Patient problems: Discomfort; Pain

  MAUDE report 24089458 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN OPENING AT MIDLINE INCISION AND THE SPINAL CORD STIMULATOR (SCS) LEADS WERE EXPOSED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Wound Dehiscence

  MAUDE report 23962203 ↗
• InjuryDec 30, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920618 ↗
• InjuryDec 18, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT HAD A BICYCLE ACCIDENT AND THEN EXPERIENCED LOSS OF STIMULATION. HIGH IMPEDANCES WERE OBSERVED ON THE SPINAL CORD STIMULATION (SCS) LEAD. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD WAS REMOVED AND REPLACED. POST OPERATIVELY, THE PATIENT WAS DOING WELL. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS RETAINED BY THE CUSTOMER.

  Patient problems: Pain

  MAUDE report 23842934 ↗
• InjuryNov 18, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT FOLLOWING A NON-DEVICE RELATED ACCIDENT THE PATIENT EXPERIENCED A RETURN OF THEIR PRE-EXISTING PAIN AND INADEQUATE STIMULATION CAUSED BY HIGH IMPEDANCE READINGS ON THE SPINAL CORD STIMULATION LEAD. THE MODEL NUMBER AND SERIAL NUMBER OF THAT LEAD CANNOT BE OBTAINED DESPITE GOOD FAITH EFFORTS. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH A NEW LEAD WAS IMPLANTED. NO DEVICES WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Device Overstimulation of Tissue; Pain

  MAUDE report 23586668 ↗
• InjuryNov 5, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT LEAD REPLACEMENT SURGERY DUE TO LEAD DISPLACEMENT, WHICH PREVENTED STIMULATION FROM REACHING THE TARGETED PAINFUL AREA. THIS ISSUE WAS CONFIRMED THROUGH MEDICAL IMAGING. THE PATIENTS POST-OPERATIVE CONDITION IS STABLE. THE EXPLANTED LEADS WILL NOT BE ANALYZED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 23478663 ↗
• InjuryOct 29, 2025High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT ONE OF TWO SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES, AND THE PATIENTS PAIN AREA WAS SPREADING. THEREFORE, THE PATIENT UNDERWENT A PROCEDURE WHERE TWO LEADS WERE REPLACED. THERE WERE NO ADVERSE EVENTS REPORTED POSTOPERATIVELY. THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 23411509 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328851 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN UNDER GENERAL ANESTHESIA FOR THE SECOND STAGE PROCEDURE TO IMPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) AND CONNECT IT TO THE ALREADY IMPLANTED LEAD. DURING THIS IPG IMPLANT PROCEDURE, THE PHYSICIAN DISCOVERED SWELLING AND PUS AT THE LEAD SITE. AS A RESULT, THE IPG IMPLANTATION WAS CANCELLED, AND THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS EXPECTED TO MAKE A FULL RECOVERY. THE SERIAL AND LOT NUMBERS OF THE LEAD CANNOT BE OBTAINED DESPITE GOOD FAITH EFFORTS. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Bacterial Infection; Purulent Discharge

  MAUDE report 22079361 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN ATTEMPTED TO CUT SCAR TISSUE THAT DEVELOPED AROUND THE LEAD AND LEAD EXTENSION OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM TO LOOSEN IT. THE PHYSICIAN WAS UNABLE TO REMOVE THE LEAD EXTENSION AND DECIDED TO CUT AND EXPLANT BOTH THE LEAD AND LEAD EXTENSION. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISCARDED BY THE FACILITY.

  Patient problems: Scar Tissue

  MAUDE report 21670725 ↗
• InjuryFeb 21, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT FOLLOWING AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE (MFR 3006630150-2025-00684), THE PATIENT EXPERIENCED OVERSTIMULATION FROM THE SPINAL CORD STIMULATION (SCS) LEAD. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 21440140 ↗
• InjuryDec 5, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LESS PAIN RELIEF IN THE NECK DUE TO LEAD MIGRATION THAT WAS CONFIRMED VIA X-RAY. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN USE.

  Patient problems: Pain

  MAUDE report 20854212 ↗
• InjuryNov 26, 2024High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD IMPEDANCES. IT WAS NOTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED AND WILL NOT BE RETURN AS IT WAS DISCARDED AT THE FACILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20786994 ↗
• InjuryOct 30, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION WHICH WAS CONFIRMED THROUGH X-RAY. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 20575398 ↗
• MalfunctionOct 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A SPINAL CORD STIMULATOR (SCS) IMPLANT PROCEDURE HOWEVER THE ANESTHESIA WAS NOT ABLE TO KEEP THE PATIENTS OXYGEN LEVEL STABLE DURING THE PROCEDURE AND WAS ABORTED. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE SCS LEAD WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 20435110 ↗
• InjuryJul 14, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD NUMBNESS, WEAKNESS, AND PAIN IN THE RIGHT ARM TO THE POINT OF BEING UNABLE TO HOLD ONTO THINGS. LEAD CHECK SHOWED THAT THE RIGHT LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Muscle Weakness/Atrophy; Numbness; Pain

  MAUDE report 19737182 ↗
• InjuryJun 27, 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 MIDLINE INCISION AS IT WAS NOT HEALING PROPERLY FOLLOWING THE IMPLANT PROCEDURE. SYMPTOM OF DRAINAGE WAS NOTED. THE PATIENT WENT THROUGH TWO ROUNDS OF ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Bacterial Infection; Fluid Discharge; Impaired Healing

  MAUDE report 19623430 ↗
• InjuryJun 11, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT PATIENT LEADS HAD MIGRATED AND WAS NOT ABLE TO COVER PATIENTS PAIN AREA. IT WAS NOTED ALSO THAT PATIENTS ANCHOR CAUSE DISCOMFORT. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY.

  Patient problems: Pain

  MAUDE report 19509406 ↗
• InjuryJun 11, 2024Unexpected Therapeutic Results; Charging Problem; Wireless Communication Problem; Migration; Unexpected Therapeutic Results; Charging Problem; Wireless Communication Problem; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE LEAD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM DUE TO MIGRATION AND WAS SCHEDULED FOR A LEAD REPLACEMENT PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT STATED THAT THEY BEGAN TO EXPERIENCE DIFFICULTY CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG), AND WAS NOT ABLE TO CONNECT TO THE CLINICIAN PROGRAMMER, THEREFORE, THE PHYSICIAN DECIDED TO REPLACE THE IPG DURING THE LEAD REVISION PROCEDURE. DURING THE PROCEDURE AN X-RAY WAS TAKEN AND IT CONFIRMED THAT THE LEAD HAD MIGRATED TO THE THORACIC LEVEL FROM THE CERVICAL LEVELS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS DOING WELL POST OPERATIVELY.

  Patient problems: Pain

  MAUDE report 19507420 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED DISCOMFORT IN THE NECK AND SHOULDERS NEAR THE LEAD SITE. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION DURING WHICH THE LEAD PLACED IN THE NECK WAS EXPLANTED. POSTOPERATIVELY, THE PATIENTS NECK AND SHOULDER DISCOMFORT DISSIPATED. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Discomfort

  MAUDE report 19047065 ↗
• InjuryMar 19, 2024Adverse 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933985 ↗
• InjuryMar 15, 2024Migration; Migration

  IT WAS REPORTED THAT DURING AN IPG UPGRADE PROCEDURE, THE PHYSICIAN NOTICED THAT THE PATIENTS LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE, AND THE PHYSICIAN WAS ABLE TO MOVED BACK THE LEADS BACK TO ITS ORIGINAL POSITION. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18910567 ↗

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-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-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-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-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-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-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.