Clik™ X MRI SC-4319Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729905325), received between Jun 5, 2017 and Apr 14, 2025 — classified as 27 injuries.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 27 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE CLIK ANCHOR SITE OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM WHILE THE STIMULATION IS IN USE. ADJUSTMENTS TO THE STIMULATION WERE PERFORMED, HOWEVER DID NOT ALLEVIATE THE PAIN WHILE THE SYSTEM WAS IN USE. THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS THE PAIN IN WHICH THE PHYSICIAN OPENED THE INCISION SITE AND MADE THE ORIGINAL LOOP AROUND THE ANCHOR STRAIGHT AND THE WHEN THE STIMULATION WAS TURNED ON THE PATIENT EXPERIENCED PAIN AGAIN. THE CLIK ANCHOR WAS REPOSITIONED 15CM AWAY FROM THE ORIGINAL LOCATION, THE STIMULATION WAS TURNED ON AGAIN, AND THE PAIN RETURNED. THE PHYSICIAN THEN REPOSITIONED THE LEAD 10CM AND THEN 5CM BACKWARDS FROM THE EPIDURAL SPACE, STIMULATION WAS TURNED ON AGAIN, AND THE PAIN RETURNED. THE PHYSICIAN ASSESSED THAT THE STIMULATION IRRITATES THE EPIDURAL FAT AND NOTHING COULD BE DONE TO RESOLVE THE PAIN, HE THEREFORE DECIDED TO EXPLANT THE ENTIRE SYSTEM.

  Patient problems: Implant Pain

  MAUDE report 21836341 ↗
• InjuryJan 8, 2025Adverse 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 THE CLIK ANCHOR SHAKING WHEN THE OUTPUT OF STIMULATION WAS INCREASED. THE PHYSICIAN STATED THAT HE FELT A PULSATING MOVEMENT WHEN THE CLIK ANCHOR PART WAS SHAKING. NO IMPEDANCE ABNORMALITIES HAVE OCCURRED. THE PATIENT LATER EXPERIENCED INCREASED PAIN AT THE CLIK ANCHOR SITE. THE PHYSICIAN CONSIDERED THE PAIN DUE TO THE FAT LAYER AT THE SITE BEING THIN. AN X-RAY WAS TAKEN AND THE MIGRATION OF THE LEAD AND CLIK ANCHOR WERE NOT CONFIRMED. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPOSITION THE CLIK ANCHOR A LITTLE DEEPER, SO THAT IT IS NOT PROTRUDING FROM THE SURFACE OF THE BODY. THE PATIENT IS DOING WELL POSTOPERATIVELY AND THERE IS NO PAIN IN THE ANCHOR AREA. STIMULATION ADJUSTMENT WAS PERFORMED AND PARESTHESIA WAS INDUCED IN THE PAIN AREA.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 21107944 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE ANCHOR SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE CASING OF THE ANCHOR WAS REMOVED. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Discomfort

  MAUDE report 20513263 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LUMP ON THE MIDLINE INCISION. THE PATIENT UNDERWENT A REVISION WHEREIN THE PHYSICIAN CUT A SCAR TISSUE AND SUTURED THE SPINAL CORD STIMULATION (SCS) LEAD WITH THE SAME ANCHOR. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Scar Tissue

  MAUDE report 20186078 ↗
• InjurySep 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENTS CLIK ANCHOR WAS LOOSE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CLIK ANCHOR WAS REPOSITIONED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE DEVICE REMAINED IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797195 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE ANCHOR SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE POCKET WAS OPENED AND THEN DISSECTED LATERALLY ALONG THE SPINE IN ORDER TO CREATE A BIGGER POCKET AND BE ABLE TO HIDE THE ANCHOR. NOTHING WAS EXPLANTED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Implant Pain

  MAUDE report 16961266 ↗
• InjurySep 6, 2022Adverse 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 CLIK ANCHOR SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE CLIK ANCHOR, LEAD, AND LEAD EXTENSION WERE EXPLANTED. POST OPERATIVELY, THE PATIENT WAS DOING WELL. CULTURES TAKEN CONFIRMED INFECTION. THE DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED FOR ANALYSIS.

  Patient problems: Unspecified Infection

  MAUDE report 15363446 ↗
• InjuryJan 7, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. THE LEAD AND IPG WERE ADJUSTED AND THE CLIK ANCHOR WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13189337 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN NEAR THE ANCHOR SITE. THERE WERE NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR REVISION PROCEDURE WHEREIN THE LEADS WERE REPLACED AS THEY WERE DAMAGED DURING THE PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND EXPLANTED DEVICES WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 13163864 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT AT THE ANCHOR SITE AND THE PAIN WORSEN WHEN LAYING ON THE SIDE. THE PAIN UNDERWENT A REVISION WHERE IN THE ANCHOR WAS BURIED DEEPER. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Discomfort; Pain

  MAUDE report 12598492 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CLIK ANCHOR THAT HAD PROTRUDED AND A BED SORE WAS CONFIRMED AROUND THAT AREA. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE ENTIRE SPINAL CORD STIMULATOR SYSTEM IN CONSIDERATION OF THE RISK OF INFECTION. THE PHYSICIAN STATED THAT THE PATIENT HAD EXPERIENCED WEIGHT LOSS AND THERE IS NO RELATION BETWEEN THE IMPLANTED DEVICES AND THIS EVENT. NO INFECTION WAS OBSERVED DURING THE EXPLANT PROCEDURE. ALL EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY.

  Patient problems: Erosion; Pressure Sore/Ulcer; Weight Changes

  MAUDE report 11675870 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT MIDLINE DUE TO A LOOSE ANCHOR. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING NAUSEA AND VOMITING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS REATTACHED AND IPG AND LEADS TOGETHER WITH THE CLIK ANCHORS WERE REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT HAS POST-OPERATIVE PAIN. THE PHYSICIAN SUSPECTED A DURA PUNCTURE AND ADMINISTERED A BLOOD PATCH AT THE END OF THE REVISION SURGERY.

  Patient problems: Nausea; Pain; Vomiting

  MAUDE report 11478199 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SYMPTOMS OF SMALL LUMP AT THE LEAD ENTRY INCISION SITE AND SMALL OOZING CYST AT THE ANCHOR SITE WERE NOTED. IT WAS NOT CONFIRMED IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICES WERE REMOVED AND WERE NOT RETURNED.

  Patient problems: Bacterial Infection; Fluid Discharge; No Code Available

  MAUDE report 10964332 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED SOME PAIN AND IRRITATION AT THE ANCHOR SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHOR WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available; Pain; Skin Irritation

  MAUDE report 9441188 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENTS CLIK ANCHOR WAS SUPERFICIAL AND CAUSING PAIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CIK ANCHOR WAS REPLACED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available; Pain

  MAUDE report 8769997 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION EVEN IF THE DEVICE HAD BEEN TURNED OFF. IT WAS ALSO REPORTED THAT THE PATIENT HAD SORENESS AROUND THE ANCHOR SITE. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND WAS GIVEN PAIN MEDICATION.

  Patient problems: Discomfort; Undesired Nerve Stimulation

  MAUDE report 8452363 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING TENDERNESS OVER THE MIDLINE INCISION. THE PATIENT UNDERWENT AN ANCHOR REVISION PROCEDURE WHEREIN THE PHYSICIAN BURIED IT DEEPER. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8428656 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AT THE ANCHOR SITE. IT WAS MENTIONED THAT THE ANCHOR HAD COME LOOSE AND WAS PUSHING THROUGH THE SKIN. NO SKIN BREAKAGE WAS NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available; Pain

  MAUDE report 8419046 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE ANCHOR SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE ANCHOR WILL BE MOVED DEEPER.

  Patient problems: Pain

  MAUDE report 7708343 ↗
• InjuryJul 12, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  A REPORT WAS RECEIVED THAT THE PATIENTS ANCHOR WAS SOMEWHAT PROTRUDING BUT NO SKIN BREAKAGE WAS NOTED. THE PATIENT UNDERWENT SURGERY TO SUTURE THE ANCHOR DOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7684404 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT ON WHERE THE ANCHORS WAS BURIED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHORS WHERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Discomfort

  MAUDE report 7390989 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. THE PATIENT UNDERWENT A REVISION WHEREIN THE CLIK ANCHOR WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 7273497 ↗
• InjuryOct 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE ANCHORS WERE CAUSING THORACIC PAIN TO THE PATIENT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ANCHORS WERE BURIED DEEPER.

  Patient problems: Pain

  MAUDE report 6909673 ↗
• InjurySep 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING MIDLINE PAIN. IT WAS ALSO REPORTED THAT THE MAIN REASON FOR ANCHOR REVISION WAS DISCOMFORT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CLIK ANCHOR WAS RELOCATED BY CUTTING THE SUTURE AND RE-SUTURED WITH A NEW FIXATE. THE PATIENT WAS DOING POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 6857833 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING IRRITATION AT THE CLIK ANCHOR SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CLIK ANCHOR WAS REPLACED AND PLACED DEEPER. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Irritation

  MAUDE report 6720084 ↗

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-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-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-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-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.