Evoke® Active Anchor Kit 3043 (UDI 09352307000810)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 09352307000810), received between Nov 27, 2023 and Sep 25, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Migration” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN THERAPY COVERAGE. AN X-RAY WAS OBTAINED WHICH REVEALED MIGRATION OF BOTH LEADS. THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20301428 ↗
• InjurySep 23, 2024Inappropriate/Inadequate Shock/Stimulation; Migration; Inappropriate/Inadequate Shock/Stimulation; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN THERAPY COVERAGE. AN X-RAY WAS OBTAINED WHICH REVEALED MIGRATION OF BOTH LEADS. THE EVOKE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20286034 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO A LEAD MIGRATION AND WOUND BREAKDOWN.

  Patient problems: Impaired Healing

  MAUDE report 20129067 ↗
• InjuryApr 1, 2024Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED THE LOSS OF STIMULATION. DURING TROUBLESHOOTING, THE REPORTED COVERAGE DID NOT MATCH THE INITIAL LEAD PLACEMENT. AN EPIDURAL INJECTION WAS ADMINISTERED USING FLUOROSCOPY, WHICH VERIFIED THAT THE LEADS HAD MIGRATED. HOWEVER THE PATIENT IS RECEIVING ADEQUATE COVERAGE WITH THEIR CURRENT PROGRAM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19016671 ↗
• InjuryMar 28, 2024Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED THE LOSS OF STIMULATION. DURING TROUBLESHOOTING, THE REPORTED COVERAGE DID NOT MATCH THE INITIAL LEAD PLACEMENT. AN EPIDURAL INJECTION WAS ADMINISTERED USING FLUOROSCOPY, WHICH VERIFIED THAT THE LEADS HAD MIGRATED. HOWEVER THE PATIENT IS RECEIVING ADEQUATE COVERAGE WITH THEIR CURRENT PROGRAM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18999711 ↗
• InjuryMar 13, 2024Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AND A MOTOR RESPONSE. THE EVOKE SCS SYSTEM AND A PHYSICIAN EXAM CONFIRMED THE PAIN WAS DUE TO LEAD MIGRATION CAUSING UNINTENDED STIMULATION. A LEAD REVISION WAS PERFORMED THREE DAYS LATER. POST PROCEDURE, THE PATIENT WAS REPORTED TO BE RECEIVING ADEQUATE THERAPY.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 18899757 ↗
• InjuryDec 27, 2023Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED TURNING OVER IN BED AND FEELING A POPPING SENSATION AT THE SPINE INCISION SITE. AN X-RAY REVEALED THE IMPLANTED LEADS HAD MIGRATED. A REVISION PROCEDURE WAS COMPLETED REPLACING THE LEADS AND ANCHORS. FOLLOWING THE REVISION PROCEDURE, THE PATIENT WAS PROGRAMMED INTO CLOSED-LOOP THERAPY WITH ADEQUATE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18406552 ↗
• InjuryDec 23, 2023Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED TURNING OVER IN BED AND FEELING A POPPING SENSATION AT THE SPINE INCISION SITE. AN X-RAY REVEALED THE IMPLANTED LEADS HAD MIGRATED. A REVISION PROCEDURE WAS COMPLETED REPLACING THE LEADS AND ANCHORS. FOLLOWING THE REVISION PROCEDURE, THE PATIENT WAS PROGRAMMED INTO CLOSED-LOOP THERAPY WITH ADEQUATE PAIN RELIEF.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18389821 ↗
• InjuryDec 7, 2023Adverse 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 REPORTED EXPERIENCING PAIN AT THE REGION OF THE ANCHOR USED WITH THE SCS LEAD. DURING THE REVISION PROCEDURE, THE LEADS COULD NOT BE FULLY RE-INSERTED INTO THE CLOSED LOOP STIMULATOR (CLS) SO THE SCS SYSTEM WAS REPLACED.

  Patient problems: Implant Pain

  MAUDE report 18288646 ↗
• InjuryNov 27, 2023Adverse 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 REPORTED EXPERIENCING PAIN AT THE REGION OF THE ANCHOR USED WITH THE SCS LEAD. DURING THE REVISION PROCEDURE, THE LEADS COULD NOT BE FULLY RE-INSERTED INTO THE CLOSED LOOP STIMULATOR (CLS) SO THE SCS SYSTEM WAS REPLACED.

  Patient problems: Implant Pain

  MAUDE report 18210978 ↗