Evoke® CAP12 Percutaneous Lead Kit - 60 cm 3008 (UDI 09352307000773)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 09352307000773), received between May 30, 2023 and Sep 25, 2024 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “High impedance” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024High impedance; High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE THERAPY DUE TO A DISCONNECTED ELECTRODE. TROUBLESHOOTING WAS UNSUCCESSFUL. THE LEAD WAS REVISED WHICH RESOLVED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20302976 ↗
• InjurySep 25, 2024High impedance; High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE THERAPY DUE TO A DISCONNECTED ELECTRODE. TROUBLE SHOOTING WAS UNSUCCESSFUL. THE LEAD WAS REVISED WHICH RESOLVED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20299820 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE FOR AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, AN EPIDURAL PUNCTURE OCCURRED WHILE IMPLANTING THE LEADS. AN EPIDURAL BLOOD PATCH PROCEDURE WAS PERFORMED. THE PATIENT REPORTED EXPERIENCING PAIN IN THEIR RIGHT LEG POST PROCEDURE. IT HAD BEEN REPORTED THAT THE PATIENT HAS BEEN RECOVERING WELL.

  Patient problems: Limb Pain

  MAUDE report 19955516 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE FOR AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, AN EPIDURAL PUNCTURE OCCURRED WHILE IMPLANTING THE LEADS. AN EPIDURAL BLOOD PATCH PROCEDURE WAS PERFORMED. THE PATIENT REPORTED EXPERIENCING PAIN IN THEIR RIGHT LEG POST PROCEDURE. IT HAD BEEN REPORTED THAT THE PATIENT HAS BEEN RECOVERING WELL.

  Patient problems: Limb Pain

  MAUDE report 19946405 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED EXPERIENCING POST-SURGERY PAIN FOLLOWING IMPLANT OF EVOKE SPINAL CORD STIMULATION (SCS) TRIAL SYSTEM. THE PATIENT¿S SCS SYSTEM WAS EXPLANTED PRIOR TO ANY PROGRAMMING.

  Patient problems: Pain

  MAUDE report 19644996 ↗
• InjuryApr 18, 2024High impedance; High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN COVERAGE. IMPEDANCE CHECK REVEALED MULTIPLE DISCONNECTED ELECTRODES. ADEQUATE PAIN COVERAGE WAS NOT ACHIEVED BY REPROGRAMMING. THE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19137039 ↗
• InjuryApr 5, 2024Adverse 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 PAIN IN THEIR RIB AREA. X-RAY IMAGING REVEALED THE RIGHT LEAD MAY HAVE BEEN AGITATING THE NEARBY NERVE ROOT. ORAL STEROIDS WERE ADMINISTERED TO ADDRESS ANY INFLAMMATION, BUT THE SYMPTOMS DID NOT RESOLVE. A REVISION PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD. AFTER THE PROCEDURE, THE PATIENT WAS NO LONGER EXPERIENCING RIB PAIN AND IS RECEIVING ADEQUATE THERAPY.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 19052428 ↗
• InjuryMar 25, 2024High impedance; High impedance

  DURING THE IMPLANT OF AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE LEAD WAS INSERTED INTO THE CLOSED LOOP STIMULATOR (CLS) HEADER, THE SET SCREW WAS TIGHTENED AND DISCONNECTED ELECTRODES WERE IDENTIFIED. AN ATTEMPT TO REPOSITION THE LEAD IN THE CLS WAS UNSUCCESSFUL, AS THE LEAD COULD NOT BE REMOVED. THE PHYSICIAN MADE THE DECISION TO COMPLETE THE PROCEDURE WITH THE DISCONNECTIONS SINCE THE SECOND LEAD WAS SHOWING IMPEDANCES WITHIN RANGE. A REVISION PROCEDURE WAS PERFORMED, AND THE LEAD WAS ABLE TO BE REMOVED AND REINSERTED IN THE HEADER. FOLLOWING THE PROCEDURE, THE IMPEDANCES WERE WITHIN RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976271 ↗
• InjuryJan 25, 2024Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN PAIN THERAPY COVERAGE. AN X-RAY REVEALED LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. THE PATIENT'S THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18582649 ↗
• InjuryJan 11, 2024Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN PAIN THERAPY COVERAGE. AN X-RAY REVEALED LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. THE PATIENT'S THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18498370 ↗
• InjuryJan 11, 2024Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED NO LONGER RECEIVING PAIN COVERAGE. IT WAS IDENTIFIED THAT THE IMPLANTED LEADS HAD MIGRATED. THE SCS SYSTEM WAS REPLACED DURING A REVISION PROCEDURE. THE IMPEDANCES POST PROCEDURE WERE WITHIN ACCEPTABLE RANGE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18497811 ↗
• InjuryJan 5, 2024Migration; Migration

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED NO LONGER RECEIVING PAIN COVERAGE. IT WAS IDENTIFIED THAT THE IMPLANTED LEADS HAD MIGRATED. THE SCS SYSTEM WAS REPLACED DURING A REVISION PROCEDURE. THE IMPEDANCES POST PROCEDURE WERE WITHIN ACCEPTABLE RANGE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18450176 ↗
• InjuryDec 13, 2023High impedance; High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS SEEN BY THE PAIN PHYSICIAN DUE TO INADEQUATE PAIN COVERAGE WHICH REVEALED MULTIPLE DISCONNECTED ELECTRODES AND SHORTS. REPROGRAMMING WAS ABLE TO RECOVER PAIN COVERAGE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE TO RESOLVE THE DISCONNECTED ELECTRODES.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18318632 ↗
• InjuryNov 27, 2023High impedance; High impedance

  A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS SEEN BY THE PAIN PHYSICIAN DUE TO INADEQUATE PAIN COVERAGE WHICH REVEALED MULTIPLE DISCONNECTED ELECTRODES AND SHORTS. REPROGRAMMING WAS ABLE TO RECOVER PAIN COVERAGE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE TO RESOLVE THE DISCONNECTED ELECTRODES

  Patient problems: Inadequate Pain Relief

  MAUDE report 18210134 ↗
• InjuryNov 12, 2023Migration; Migration

  THE PATIENT HAD FALLEN RESULTING IN THE PATIENT'S EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM TO MIGRATE FROM ITS ORIGINAL POSITION. A REPOSITIONING PROCEDURE WAS PERFORMED SUCCESSFULLY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18117458 ↗
• MalfunctionMay 30, 2023Migration; Migration

  DURING A ROUTINE FOLLOW UP POST OPERATIVE VISIT FOR PROGRAMMING, IT WAS NOTED THAT THE PATIENT DID NOT RECEIVE PARESTHESIA FROM THE RIGHT LEAD. X RAY TAKEN DURING THE VISIT SHOWED LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE. THE PATIENT CONTINUES TO HAVE PAIN COVERAGE THROUGH THE LEFT LEAD TOWARDS THE LEFT SIDE OF THEIR BODY.A REVISION SURGERY IS TO BE SCHEDULED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17028290 ↗