Evoke® CAP12 Percutaneous Lead Kit - 90 cm 3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 09352307001657), received between Jul 9, 2024 and Sep 30, 2026 — classified as 25 injuries.

The most frequently reported specific device problem is “High impedance” (10 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, 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 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Migration

  A patient implanted with the Evoke Spinal Cord Stimulation (SCS) System reported pain at the midline incision. X-rays confirmed lead migration. Therapy remained adequate; however, the migrated lead bunched beneath the skin, causing significant discomfort. A lead revision was completed, and the midline incision site pain was substantially reduced, though post-operative pain persisted.

  Patient problems: Implant Pain

  MAUDE report 50945208 ↗
• InjurySep 30, 2026Migration

  A patient implanted with the Evoke Spinal Cord Stimulation (SCS) System reported pain at the midline incision. X-rays confirmed lead migration. Therapy remained adequate; however, the migrated lead bunched beneath the skin, causing significant discomfort. A lead revision was completed, and the midline incision site pain was substantially reduced, though post-operative pain persisted.

  Patient problems: Implant Pain

  MAUDE report 50945206 ↗
• InjurySep 21, 2026Patient Device Interaction Problem

  Patient problems: Bradycardia

  MAUDE report 50842596 ↗
• InjurySep 21, 2026Patient Device Interaction Problem

  Patient problems: Bradycardia

  MAUDE report 50842595 ↗
• InjuryJul 8, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. AN IMPEDANCE CHECK IDENTIFIED DISCONNECTED ELECTRODES, RESULTING IN LOSS OF MAGNETIC RESONANCE IMAGERY (MRI) COMPATIBILITY. AN X-RAY REVEALED LEAD MIGRATION. REPROGRAMMING WAS PERFORMED BUT ADEQUATE PAIN RELIEF COULD NOT BE ACHIEVED. THE EVOKE SCS SYSTEM WAS SUBSEQUENTLY EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25746370 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A TRIAL WITH EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. FOLLOWING REMOVAL OF TRIAL LEADS THE PATIENT REPORTED FLUID DISCHARGE FROM THE INCISION SITE. THE PATIENT WAS EVALUATED IN EMERGENCY ROOM, AND THE INCISION SITE WAS SUTURED.

  Patient problems: Fluid Discharge

  MAUDE report 24903966 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A TRIAL WITH EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. FOLLOWING REMOVAL OF TRIAL LEADS THE PATIENT REPORTED FLUID DISCHARGE FROM THE INCISION SITE. THE PATIENT WAS EVALUATED IN EMERGENCY ROOM, AND THE INCISION SITE WAS SUTURED.

  Patient problems: Fluid Discharge

  MAUDE report 24896830 ↗
• InjuryMar 11, 2026High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF AFTER A FALL UNRELATED TO THE EVOKE SCS SYSTEM. AN IMPEDANCE CHECK IDENTIFIED DISCONNECTED ELECTRODES AND HIGH IMPEDANCES ON ONE (1) LEAD. A REVISION PROCEDURE WAS COMPLETED AND THERAPY RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24574287 ↗
• InjuryMar 11, 2026High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF AFTER A FALL UNRELATED TO THE EVOKE SCS SYSTEM. AN IMPEDANCE CHECK IDENTIFIED DISCONNECTED ELECTRODES AND HIGH IMPEDANCES ON ONE (1) LEAD. A REVISION PROCEDURE WAS COMPLETED AND THERAPY RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24567267 ↗
• InjuryJan 6, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN IMPEDANCE CHECK, WHICH IDENTIFIED A DISCONNECTED ELECTRODE IMPACTING THE SYSTEM¿S MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY. THE PATIENT REQUIRED AN MRI, AND A LEAD REPLACEMENT WAS PLANNED TO RESTORE THE EVOKE SCS MRI COMPATIBILITY. DURING THE LEAD REVISION PROCEDURE, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE, AND THE PROCEDURE COULDN¿T BE COMPLETED AS PLANNED. AS A RESULT, THE EVOKE SCS SYSTEM WAS EXPLANTED INSTEAD OF PROCEEDING WITH THE PLANNED LEAD REPLACEMENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23976134 ↗
• InjuryJan 6, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN IMPEDANCE CHECK, WHICH IDENTIFIED A DISCONNECTED ELECTRODE IMPACTING THE SYSTEM¿S MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY. THE PATIENT REQUIRED AN MRI, AND A LEAD REPLACEMENT WAS PLANNED TO RESTORE THE EVOKE SCS MRI COMPATIBILITY. DURING THE LEAD REVISION PROCEDURE, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE, AND THE PROCEDURE COULDN¿T BE COMPLETED AS PLANNED. AS A RESULT, THE EVOKE SCS SYSTEM WAS EXPLANTED INSTEAD OF PROCEEDING WITH THE PLANNED LEAD REPLACEMENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23976129 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR SKIN PERFORATION AT THE LEAD IMPLANT SITE. THE EVOKE SCS SYSTEM WAS EXPLANTED, AND ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: Erosion

  MAUDE report 23727089 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR SKIN PERFORATION AT THE LEAD IMPLANT SITE. THE EVOKE SCS SYSTEM WAS EXPLANTED, AND ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: Erosion

  MAUDE report 23727079 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR AN INFECTION AT THE EVOKE CAP12 PERCUTANEOUS LEAD IMPLANT SITE. TOPICAL SOLUTION AND ANTIBIOTICS WERE PRESCRIBED TO TREAT THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23521894 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR AN INFECTION AT THE EVOKE CAP12 PERCUTANEOUS LEAD IMPLANT SITE. TOPICAL SOLUTION AND ANTIBIOTICS WERE PRESCRIBED TO TREAT THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23521891 ↗
• InjuryJul 16, 2025High impedance; High impedance

  DURING AN IMPEDANCE CHECK PERFORMED FOR A PATIENT IMPLANTED WITH A PERMANENT EVOKE SPINAL CORD STIMULATION (SCS), DISCONNECTED ELECTRODES WERE IDENTIFIED. THE PATIENT ELECTED FOR EXPLANT OF THEIR EVOKE SCS SYSTEM TO RESOLVE THE REPORTED EVENT. THE IMPEDANCE CHECK WAS PERFORMED AS PART OF ROUTINE DEVICE CHECK BEFORE PERFORMING MAGNETIC RESONANCE IMAGING (MRI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22524449 ↗
• InjuryJul 15, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; Migration; High impedance; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF. X-RAY IMAGING IDENTIFIED A LEAD MIGRATION. AN IMPEDANCE CHECK WAS PERFORMED TO IDENTIFY HIGH IMPEDANCE. A LEAD REVISION PROCEDURE WAS COMPLETED TO RESOLVE THE REPORTED EVENT AND RESTORE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22509989 ↗
• InjuryJul 15, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF. X-RAY IMAGING IDENTIFIED A LEAD MIGRATION. AN IMPEDANCE CHECK WAS PERFORMED TO IDENTIFY HIGH IMPEDANCE. A LEAD REVISION PROCEDURE WAS COMPLETED TO RESOLVE THE REPORTED EVENT AND RESTORE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22509976 ↗
• InjuryJun 20, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION. THE PATIENT HAD REPORTED ADEQUATE PAIN RELIEF PREVIOUSLY. AN X-RAY AND IMPEDANCE CHECK WERE PERFORMED WITH NO DEVICE ISSUES IDENTIFIED. THE PATIENT REPORTED PREVIOUS FALLS; THE EVOKE SCS DIDN'T CAUSE OR CONTRIBUTE TO THE PATIENT¿S FALLS. THE PHYSICIAN ASSESSED THAT THE PATIENT¿S FALLS MAY HAVE DAMAGED THE EVOKE CLOSED LOOP STIMULATOR (CLS) AND CONTRIBUTED TO THE CHANGES IN STIMULATION. A REVISION PROCEDURE (REPORTED UNDER MANUFACTURER REPORT NUMBER: 3021836309-2025-00161) WAS PERFORMED TO REMOVE THE EVOKE CLS AND CONNECT THE LEADS TO AN EVOKE EXTERNAL CLOSED LOOP STIMULATOR (ECLS). THE STIMULATION CHANGE WAS NOT RESOLVED FOLLOWING THE REVISION PROCEDURE. FURTHER TROUBLESHOOTING PERFORMED, WITH PATIENT LEADS CONNECTED TO THE EVOKE EXTERNAL CLOSED LOOP STIMULATOR (ECLS), IDENTIFIED LEAD MIGRATION CONTRIBUTING TO THE REPORTED EVENT. AN EXPLANT PROCEDURE WAS PERFORMED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22298585 ↗
• InjuryJun 20, 2025Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION. THE PATIENT HAD REPORTED ADEQUATE PAIN RELIEF PREVIOUSLY. AN X-RAY AND IMPEDANCE CHECK WERE PERFORMED WITH NO DEVICE ISSUES IDENTIFIED. THE PATIENT REPORTED PREVIOUS FALLS; THE EVOKE SCS DIDN¿T CAUSE OR CONTRIBUTE TO THE PATIENT¿S FALLS. THE PHYSICIAN ASSESSED THAT THE PATIENT¿S FALLS MAY HAVE DAMAGED THE EVOKE CLOSED LOOP STIMULATOR (CLS) AND CONTRIBUTED TO THE CHANGES IN STIMULATION. A REVISION PROCEDURE (REPORTED UNDER MANUFACTURER REPORT NUMBER - 3021836309-2025-00161) WAS PERFORMED TO REMOVE THE EVOKE CLS AND CONNECT THE LEADS TO AN EVOKE EXTERNAL CLOSED LOOP STIMULATOR (ECLS). THE STIMULATION CHANGE WAS NOT RESOLVED FOLLOWING THE REVISION PROCEDURE. FURTHER TROUBLESHOOTING PERFORMED, WITH PATIENT LEADS CONNECTED TO THE EVOKE EXTERNAL CLOSED LOOP STIMULATOR (ECLS), IDENTIFIED LEAD MIGRATION CONTRIBUTING TO THE REPORTED EVENT. AN EXPLANT PROCEDURE WAS PERFORMED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22298582 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS EVALUATED FOR INFECTION AT THE LEAD IMPLANT SITE. THE LEAD INCISION SITE WAS WASHED OUT AND ANTIBIOTICS ADMINISTERED.

  Patient problems: Unspecified Infection

  MAUDE report 21952599 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS EVALUATED FOR INFECTION AT THE LEAD IMPLANT SITE. THE LEAD INCISION SITE WAS WASHED OUT AND ANTIBIOTICS ADMINISTERED.

  Patient problems: Unspecified Infection

  MAUDE report 21952556 ↗
• InjuryJan 8, 2025High impedance; Intermittent Shock/Stimulation; High impedance; Intermittent Shock/Stimulation

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INTERMITTENT LOSS OF STIMULATION. DISCONNECTED ELECTRODES WERE IDENTIFIED WHEN THE PATIENT CHANGED POSTURE. FLUOROSCOPY IDENTIFIED THAT BOTH LEADS WERE IN CLOSE PROXIMITY, WHICH COULD ATTRIBUTE TO THE IDENTIFIED INTERMITTENT DISCONNECTED ELECTRODES. A REVISION PROCEDURE WAS COMPLETED AND ONE OF THE IMPLANTED LEADS WAS REMOVED. INTRA-OPERATIVE IMPEDANCE CHECK DID NOT REVEAL ANY DISCONNECTED ELECTRODES. DURING THE INITIAL PROGRAMMING VISIT THREE (3) DAYS POST REVISION PROCEDURE, DISCONNECTED ELECTRODES WERE IDENTIFIED. NO ADDITIONAL INTERVENTION HAS BEEN REPORTED TO SALUDA AT THE TIME OF THIS REPORT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21108698 ↗
• InjuryJan 8, 2025High impedance; Intermittent Shock/Stimulation; High impedance; Intermittent Shock/Stimulation

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INTERMITTENT LOSS OF STIMULATION. DISCONNECTED ELECTRODES WERE IDENTIFIED WHEN THE PATIENT CHANGED POSTURE. FLUOROSCOPY IDENTIFIED THAT BOTH LEADS WERE IN CLOSE PROXIMITY, WHICH COULD ATTRIBUTE TO THE IDENTIFIED INTERMITTENT DISCONNECTED ELECTRODES. A REVISION PROCEDURE WAS COMPLETED AND ONE OF THE IMPLANTED LEADS WAS REMOVED. INTRA-OPERATIVE IMPEDANCE CHECK DID NOT REVEAL ANY DISCONNECTED ELECTRODES. DURING THE INITIAL PROGRAMMING VISIT THREE (3) DAYS POST REVISION PROCEDURE, DISCONNECTED ELECTRODES WERE IDENTIFIED. NO ADDITIONAL INTERVENTION HAS BEEN REPORTED TO SALUDA AT THE TIME OF THIS REPORT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21107796 ↗
• InjuryJul 9, 2024Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM LOST STIMULATION AFTER LIFTING A 10LB BOX ONTO THEIR SHOULDER TWO WEEKS AFTER IMPLANT. TROUBLESHOOTING WAS UNSUCCESSFUL. AN X-RAY REVEALED A LEAD MIGRATION AND STIMULATION WAS TURNED OFF. DURING THE REVISION PROCEDURE THE LEAD AND ANCHOR WERE REPLACED. A NON-SALUDA ANCHOR WAS USED AND STIMULATION WAS RESTARTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19706661 ↗