Evoke® Active Anchor Kit - L 3043Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 09352307001817), received between Dec 10, 2024 and Sep 16, 2026 — classified as 71 injuries.

The most frequently reported specific device problem is “Migration” (68 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  Patient problems: Inadequate Pain Relief

  MAUDE report 50790648 ↗
• InjurySep 16, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported a change in stimulation resulting in inadequate pain relief. X-ray imaging identified migration of both leads. Reprogramming did not restore adequate pain relief. A revision procedure was performed by replacing both leads to resolve the reported event.The patient reported non-compliance with post-operative instructions and had engaged in strenuous activities following the implant procedure.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50790645 ↗
• InjurySep 14, 2026Patient-Device Incompatibility; Migration

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for possible lead migration. The patient also reported discomfort at the Evoke Closed Loop Stimulator (CLS) implant site due to contact with the patient¿s belt. X-ray imaging confirmed migration of both Evoke leads. During the revision procedure, the physician noted that the anchors were functioning as intended and the patient¿s post-implant activity level may have contributed to the lead migration. One lead was replaced, the other lead was repositioned, the existing anchors were reused, the CLS was repositioned to a higher location.

  Patient problems: Implant Pain

  MAUDE report 50754797 ↗
• InjurySep 14, 2026Patient-Device Incompatibility; Migration

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System was evaluated for possible lead migration. The patient also reported discomfort at the Evoke Closed Loop Stimulator (CLS) implant site due to contact with the patient¿s belt. X-ray imaging confirmed migration of both Evoke leads. During the revision procedure, the physician noted that the anchors were functioning as intended and the patient¿s post-implant activity level may have contributed to the lead migration. One lead was replaced, the other lead was repositioned, the existing anchors were reused, the CLS was repositioned to a higher location.

  Patient problems: Implant Pain

  MAUDE report 50754796 ↗
• InjuryJul 30, 2026Failure to Charge; Migration

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported difficulty charging their Evoke Closed Loop Stimulator (CLS). The patient reported a previous fall; the Evoke SCS System didn¿t cause or contribute to the patient¿s fall. X-ray imaging identified migration of two (2) leads and the CLS was in an angled position. The physician elected to perform a revision procedure to replace the migrated leads and reposition the CLS. During the revision procedure, the physician encountered scar tissue and could not regain posterior access to place the new leads. As a result, the revision procedure was aborted, the patient subsequently underwent explantation of the Evoke SCS System.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50084976 ↗
• InjuryJul 30, 2026Failure to Charge; Migration

  A patient implanted with an Evoke Spinal Cord Stimulation (SCS) System reported difficulty charging their Evoke Closed Loop Stimulator (CLS). The patient reported a previous fall; the Evoke SCS System didn¿t cause or contribute to the patient¿s fall. X-ray imaging identified migration of two (2) leads and the CLS was in an angled position. The physician elected to perform a revision procedure to replace the migrated leads and reposition the CLS. During the revision procedure, the physician encountered scar tissue and could not regain posterior access to place the new leads. As a result, the revision procedure was aborted, the patient subsequently underwent explantation of the Evoke SCS System.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50084974 ↗
• InjuryJul 1, 2026High impedance; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN IMPEDANCE CHECK DURING THE INITIAL PROGRAMMING VISIT, AND DISCONNECTED ELECTRODE AND HIGH IMPEDANCES WERE IDENTIFIED. AN X-RAY REVEALED A LEAD MIGRATION. THE PATIENT REPORTED DIFFICULTY ADHERING TO POST-PROCEDURAL RESTRICTIONS. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE LEAD AND ANCHOR WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681496 ↗
• InjuryJun 30, 2026Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A BURNING SENSATION AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND A CHANGE IN STIMULATION. THE BURNING SENSATION RESOLVED WHEN STIMULATION WAS TURNED OFF; HOWEVER, TENDERNESS AT THE CLS IMPLANT SITE WAS REPORTED UPON PALPATION. MAGNETIC RESONANCE IMAGING (MRI) DID NOT IDENTIFY AN INFECTION. NO ANOMALIES WERE OBSERVED DURING THE IMPEDANCE CHECK. X-RAYS IDENTIFIED LEAD MIGRATION. REPROGRAMMING WAS ATTEMPTED BUT DID NOT RESOLVE THE REPORTED ISSUE. A REVISION PROCEDURE WAS PERFORMED, AND THE EVOKE SCS SYSTEM WAS REPLACED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Burning Sensation; Implant Pain; Inadequate Pain Relief

  MAUDE report 25664613 ↗
• InjuryJun 29, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION. X-RAY IDENTIFIED A LEAD MIGRATION. A FULL SYSTEM EXPLANT WAS SUBSEQUENTLY PERFORMED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25649769 ↗
• InjuryJun 11, 2026Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM EXPERIENCED MIDLINE INCISION DEHISCENCE FOLLOWING MULTIPLE FALLS UNRELATED TO THE EVOKE SCS SYSTEM. THE LEADS WERE OBSERVED TO BE PROTRUDING THROUGH THE INCISION SITE. NO SIGNS OF INFECTION WERE NOTED. X-RAY IDENTIFIED LEAD MIGRATION. THE EVOKE SCS SYSTEM WAS EXPLANTED AND ANTIBIOTICS WERE ADMINISTERED.

  Patient problems: Rupture

  MAUDE report 25470804 ↗
• InjuryMay 15, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. AN X-RAY IDENTIFIED MIGRATION OF BOTH LEADS. REPROGRAMMING WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE LEADS AND ANCHORS WERE REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25183214 ↗
• InjuryMay 15, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. AN X-RAY IDENTIFIED MIGRATION OF BOTH LEADS. REPROGRAMMING WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE LEADS AND ANCHORS WERE REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25183206 ↗
• InjuryMay 12, 2026Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT X-RAYS WHICH CONFIRMED MIGRATION OF BOTH LEADS. A REVISION PROCEDURE WAS PERFORMED AND THE LEADS AND ANCHORS WERE REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25147458 ↗
• InjuryMay 12, 2026Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT X-RAYS WHICH CONFIRMED MIGRATION OF BOTH LEADS. A REVISION PROCEDURE WAS PERFORMED AND THE LEADS AND ANCHORS WERE REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25147442 ↗
• OtherMay 8, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR A CHANGE IN STIMULATION. AN X-RAY CONFIRMED LEAD MIGRATION. REPROGRAMING WAS PERFORMED BUT UNSUCCESSFUL. A REVISION PROCEDURE WAS PERFORMED, AND THE LEADS AND ANCHORS WERE REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25125490 ↗
• InjuryMay 8, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR A CHANGE IN STIMULATION. AN X-RAY CONFIRMED LEAD MIGRATION. REPROGRAMING WAS PERFORMED BUT UNSUCCESSFUL. A REVISION PROCEDURE WAS PERFORMED, AND THE LEADS AND ANCHORS WERE REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25125010 ↗
• InjuryApr 20, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF ATTRIBUTED TO LEAD MIGRATION. A REVISION PROCEDURE WAS PERFORMED AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24924457 ↗
• InjuryApr 20, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF ATTRIBUTED TO LEAD MIGRATION. A REVISION PROCEDURE WAS PERFORMED AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24924455 ↗
• InjuryApr 15, 2026Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. AN X-RAY IDENTIFIED LEAD MIGRATION. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH ANCHORS AND A LEAD WERE REPLACED, AND ONE LEAD WAS REPOSITIONED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24885361 ↗
• InjuryMar 31, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED CHANGE IN STIMULATION. X-RAY WAS PERFORMED AND A LEAD MIGRATION WAS IDENTIFIED. REPROGRAMMING WAS UNABLE TO RESTORE ADEQUATE THERAPY. A LEAD REVISION WAS COMPLETED TO RESOLVE THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24740927 ↗
• InjuryMar 31, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED CHANGE IN STIMULATION. X-RAY WAS PERFORMED AND A LEAD MIGRATION WAS IDENTIFIED. REPROGRAMMING WAS UNABLE TO RESTORE ADEQUATE THERAPY. A LEAD REVISION WAS COMPLETED TO RESOLVE THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24740926 ↗
• InjuryMar 11, 2026Inadequacy of Device Shape and/or Size

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR PAIN AT THE ANCHOR IMPLANT SITE. A CORTISONE INJECTION WAS ADMINISTERED TO RELIEVE THE PAIN DURING HEALING.

  Patient problems: Implant Pain

  MAUDE report 24574304 ↗
• InjuryMar 11, 2026Inadequacy of Device Shape and/or Size

  THE PATIENT¿S SYMPTOMS PERSISTED DESPITE RECEIVING A PAIN INJECTION. A REVISION PROCEDURE WAS COMPLETED ON (B)(6) 2026, AND THE ANCHORS WERE REMOVED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Implant Pain

  MAUDE report 24567303 ↗
• InjuryMar 10, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF FOLLOWING MULTIPLE FALLS UNRELATED TO THE EVOKE SCS SYSTEM. AN X-RAY CONFIRMED LEAD MIGRATION AND THE PATIENT WAS SUBSEQUENTLY REPROGRAMMED IN AN OPEN-LOOP PROGRAM. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT MANIPULATED THE IMPLANTED EVOKE CLOSED LOOP STIMULATOR (CLS) CAUSING THE DEVICE TO ROTATE WITHIN THE POCKET AND FURTHER DISLODGED THE LEADS. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE EVOKE SCS SYSTEM WAS REPLACED.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 24557862 ↗
• InjuryMar 10, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF FOLLOWING MULTIPLE FALLS UNRELATED TO THE EVOKE SCS SYSTEM. AN X-RAY CONFIRMED LEAD MIGRATION AND THE PATIENT WAS SUBSEQUENTLY REPROGRAMMED IN AN OPEN-LOOP PROGRAM. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT MANIPULATED THE IMPLANTED EVOKE CLOSED LOOP STIMULATOR (CLS) CAUSING THE DEVICE TO ROTATE WITHIN THE POCKET AND FURTHER DISLODGED THE LEADS. A REVISION PROCEDURE WAS PERFORMED, DURING WHICH THE EVOKE SCS SYSTEM WAS REPLACED.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 24557861 ↗