Evoke® CAP12 Trial Percutaneous Lead Kit - 60 cm 3016Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 09352307000797), received between Jul 24, 2023 and Jun 22, 2026 — classified as 6 deaths, 47 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING IMPLANTATION OF THE TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PATIENT REPORTED RIGHT-SIDED OCULAR DISCOMFORT, WATERING OF THE EYE, AND PHOTOPHOBIA. NARCOTICS WERE PRESCRIBED; HOWEVER, THE INDICATION FOR NARCOTIC USE REMAINS UNKNOWN (I.E., WHETHER PRESCRIBED FOR THESE SYMPTOMS OR PRE-EXISTING PAIN). THE SCS SYSTEM WAS TURNED OFF AND REMOVED THE NEXT DAY. THE PATIENT REPORTED THAT DEVICE REMOVAL WAS PAINFUL AND PRESENTED TO THE EMERGENCY DEPARTMENT LATER THAT DAY. IMAGING DEMONSTRATED PNEUMOTHORAX AND AIR WITHIN THE SPINAL CANAL; NO INTERVENTION WAS REPORTED. THE PATIENT WAS EVALUATED BY AN OPHTHALMOLOGIST ON (B)(6) 2026, WHO RULED OUT PRIMARY OCULAR CAUSES FOR THE SYMPTOMS AND REFERRED THE PATIENT TO A NEURO-OPHTHALMOLOGIST. BETWEEN (B)(6) 2026, THE PATIENT DEVELOPED SEVERE EYE PAIN, PHOTOPHOBIA, DIPLOPIA, INSOMNIA, TACHYCARDIA, TREMORS, AND PTSD-LIKE NIGHT TERRORS. ON (B)(6) 2026, THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WITH SUSPECTED STROKE WHICH WAS LATER RULED OUT. THE PATIENT WAS HOSPITALIZED AND A DIAGNOSTIC MRI WAS PERFORMED. THE PATIENT WAS DISCHARGED WITH A RECOMMENDATION FOR NEURO-OPHTHALMOLOGY FOLLOW UP. AT THE TIME OF REPORTING, ADDITIONAL INFOR

  Patient problems: Diplopia/Double Vision; Discomfort; Eye Pain; Pain; Photophobia; Pneumothorax; Sleep Dysfunction; Tachycardia; Tics/Tremor

  MAUDE report 25576254 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING IMPLANTATION OF THE TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PATIENT REPORTED RIGHT-SIDED OCULAR DISCOMFORT, WATERING OF THE EYE, AND PHOTOPHOBIA. NARCOTICS WERE PRESCRIBED; HOWEVER, THE INDICATION FOR NARCOTIC USE REMAINS UNKNOWN (I.E., WHETHER PRESCRIBED FOR THESE SYMPTOMS OR PRE-EXISTING PAIN). THE SCS SYSTEM WAS TURNED OFF AND REMOVED THE NEXT DAY. THE PATIENT REPORTED THAT DEVICE REMOVAL WAS PAINFUL AND PRESENTED TO THE EMERGENCY DEPARTMENT LATER THAT DAY. IMAGING DEMONSTRATED PNEUMOTHORAX AND AIR WITHIN THE SPINAL CANAL; NO INTERVENTION WAS REPORTED. THE PATIENT WAS EVALUATED BY AN OPHTHALMOLOGIST ON (B)(6) 2026, WHO RULED OUT PRIMARY OCULAR CAUSES FOR THE SYMPTOMS AND REFERRED THE PATIENT TO A NEURO-OPHTHALMOLOGIST. BETWEEN (B)(6) 2026, THE PATIENT DEVELOPED SEVERE EYE PAIN, PHOTOPHOBIA, DIPLOPIA, INSOMNIA, TACHYCARDIA, TREMORS, AND PTSD-LIKE NIGHT TERRORS. ON (B)(6) 2026, THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WITH SUSPECTED STROKE WHICH WAS LATER RULED OUT. THE PATIENT WAS HOSPITALIZED AND A DIAGNOSTIC MRI WAS PERFORMED. THE PATIENT WAS DISCHARGED WITH A RECOMMENDATION FOR NEURO-OPHTHALMOLOGY FOLLOW UP. AT THE TIME OF REPORTING, ADDITIONAL INFOR

  Patient problems: Diplopia/Double Vision; Discomfort; Eye Pain; Pain; Photophobia; Pneumothorax; Sleep Dysfunction; Tachycardia; Tics/Tremor

  MAUDE report 25576253 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  DURING IMPLANTATION OF A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PHYSICIAN ENCOUNTERED DIFFICULTY PLACING THE LEADS DUE TO PATIENT ANATOMICAL CHALLENGES. ONE LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT REPORTED SEVERE PAIN WHILE IN THE POST-ANESTHESIA CARE UNIT (PACU) AND REQUESTED LEAD REMOVAL. INTRAVENOUS (IV) FENTANYL AND TORADOL WERE ADMINISTERED AND THE PATIENT WAS DISCHARGED. THE PHYSICIAN ATTRIBUTED THE PATIENT¿S SYMPTOMS TO NERVE IRRITATION THAT MAY HAVE OCCURRED DURING LEAD PLACEMENT.

  Patient problems: Pain

  MAUDE report 25531463 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  DURING IMPLANTATION OF A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PHYSICIAN ENCOUNTERED DIFFICULTY PLACING THE LEADS DUE TO PATIENT ANATOMICAL CHALLENGES. ONE LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT REPORTED SEVERE PAIN WHILE IN THE POST-ANESTHESIA CARE UNIT (PACU) AND REQUESTED LEAD REMOVAL. INTRAVENOUS (IV) FENTANYL AND TORADOL WERE ADMINISTERED AND THE PATIENT WAS DISCHARGED. THE PHYSICIAN ATTRIBUTED THE PATIENT¿S SYMPTOMS TO NERVE IRRITATION THAT MAY HAVE OCCURRED DURING LEAD PLACEMENT.

  Patient problems: Pain

  MAUDE report 25531237 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED EXPERIENCING DIAPHORESIS, LOWER BACK PAIN, AND A SENSATION OF WARMTH. THE PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT, WHERE BLOOD TEST IDENTIFIED A MINOR ELEVATION IN WHITE BLOOD CELL COUNT AND LACTIC ACID LEVELS. REDNESS OR DRAINAGE WAS NOT OBSERVED AT THE LEAD IMPLANT SITE. THE PATIENT WAS HOSPITALIZED, ANTIBIOTICS WERE ADMINISTERED AND THE LEADS WERE REMOVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2026.

  Patient problems: Diaphoresis; High White Blood Cell Count; Hot Flashes/Flushes; Pain

  MAUDE report 25353757 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERGOING A TRIAL WITH THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED HEADACHES AND DIAPHORESIS. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, WHERE A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND THE TRIAL LEADS WERE REMOVED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL, AND A MAGNETIC RESONANCE IMAGING (MRI) WAS CONDUCTED. IMAGING IDENTIFIED A LOW CEREBROSPINAL FLUID (CSF) LEVEL. NO ADDITIONAL INTERVENTION WAS REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage; Diaphoresis; Headache

  MAUDE report 25160392 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERGOING A TRIAL WITH THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED HEADACHES AND DIAPHORESIS. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, WHERE A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND THE TRIAL LEADS WERE REMOVED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL, AND A MAGNETIC RESONANCE IMAGING (MRI) WAS CONDUCTED. IMAGING IDENTIFIED A LOW CEREBROSPINAL FLUID (CSF) LEVEL. NO ADDITIONAL INTERVENTION WAS REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage; Diaphoresis; Headache

  MAUDE report 25160389 ↗
• DeathMay 6, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PROCEDURE AND INITIAL PROGRAMMING WERE COMPLETED WITHOUT ISSUE, AND THE PATIENT WAS DISCHARGED. THE SALUDA REPRESENTATIVE CALLED THE PATIENT LATER THAT EVENING, AND THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN PAIN. THE FOLLOWING MORNING, THE SALUDA REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD DIED OVERNIGHT. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN AND AUTOPSY RESULTS ARE PENDING AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092439 ↗
• DeathMay 6, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PROCEDURE AND INITIAL PROGRAMMING WERE COMPLETED WITHOUT ISSUE, AND THE PATIENT WAS DISCHARGED. THE SALUDA REPRESENTATIVE CALLED THE PATIENT LATER THAT EVENING, AND THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN PAIN. THE FOLLOWING MORNING, THE SALUDA REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD DIED OVERNIGHT. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN AND AUTOPSY RESULTS ARE PENDING AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092423 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE TRIAL PERIOD OF THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH HEADACHE, NAUSEA, AND NECK PAIN. THE TRIAL LEADS WERE REMOVED. MAGNETIC RESONANCE IMAGING (MRI) IDENTIFIED A CEREBROSPINAL FLUID (CSF) LEAK. A BLOOD PATCH PROCEDURE WAS PERFORMED. AT THE TIME OF REPORTING, THE PATIENT'S SYMPTOMS WERE REPORTED TO BE RESOLVING.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; Nausea; Neck Pain

  MAUDE report 25056289 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE TRIAL PERIOD OF THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH HEADACHE, NAUSEA, AND NECK PAIN. THE TRIAL LEADS WERE REMOVED. MAGNETIC RESONANCE IMAGING (MRI) IDENTIFIED A CEREBROSPINAL FLUID (CSF) LEAK. A BLOOD PATCH PROCEDURE WAS PERFORMED. AT THE TIME OF REPORTING, THE PATIENT'S SYMPTOMS WERE REPORTED TO BE RESOLVING.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; Nausea; Neck Pain

  MAUDE report 25056286 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY ONE WEEK FOLLOWING REMOVAL OF THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM'S TRIAL LEADS, THE PATIENT WAS EVALUATED FOR PAIN AND INFECTION, AND SUBSEQUENTLY UNDERWENT A LAMINECTOMY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24729771 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING A TRIAL IMPLANT PROCEDURE FOR THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, EXCESSIVE BLEEDING WAS OBSERVED AT THE NEEDLE ENTRY SITE. THE PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO EVIDENCE OF HEMATOMA. THE INCISION SITE WAS REDRESSED, THE BLEEDING SUBSIDED WITHOUT FURTHER INTERVENTIONS AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24317171 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING A TRIAL IMPLANT PROCEDURE FOR THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, EXCESSIVE BLEEDING WAS OBSERVED AT THE NEEDLE ENTRY SITE. THE PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT, A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO EVIDENCE OF HEMATOMA. THE INCISION SITE WAS REDRESSED, THE BLEEDING SUBSIDED WITHOUT FURTHER INTERVENTIONS AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24317166 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  THREE (3) DAYS AFTER REMOVAL OF THE EVOKE SCS TRIAL LEADS, THE PATIENT WAS EVALUATED IN A HOSPITAL SETTING FOR INCREASED BACK AND ABDOMINAL PAIN AND PARESIS IN LOWER LIMBS. A SPINAL BLOOD CLOT WAS TREATED WITH SURGICAL INTERVENTION.

  Patient problems: Abdominal Pain; Embolism/Embolus; Pain; Paresis

  MAUDE report 24111924 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  THREE (3) DAYS AFTER REMOVAL OF THE EVOKE SCS TRIAL LEADS, THE PATIENT WAS EVALUATED IN A HOSPITAL SETTING FOR INCREASED BACK AND ABDOMINAL PAIN AND PARESIS IN LOWER LIMBS. A SPINAL BLOOD CLOT WAS TREATED WITH SURGICAL INTERVENTION.

  Patient problems: Abdominal Pain; Embolism/Embolus; Pain; Paresis

  MAUDE report 24111922 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL..

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23836497 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM TRIAL, THE PATIENT'S CAREGIVER REPORTED THE PATIENT WAS EXPERIENCING PAIN. DURING EVALUATION IN THE EMERGENCY DEPARTMENT, INFECTION WAS IDENTIFIED AND ANTIBIOTICS WERE PRESCRIBED. DIAGNOSTICS & ULTRASOUND SCAN IDENTIFIED A KIDNEY STONE OBSTRUCTING THE KIDNEY, WHICH MAY HAVE CONTRIBUTED TO THE INFECTION. PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23836496 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A TRIAL IMPLANT PROCEDURE FOR THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PATIENT REPORTED PAIN IN THEIR LEFT LOWER LIMB. THE LEADS WERE REMOVED, AND A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED. NO ANOMALIES WERE DETECTED IN THE MRI SCAN AND THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED. THREE (3) DAYS LATER, THE PATIENT REPORTED THEIR SYMPTOM HAD RESOLVED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Limb Pain

  MAUDE report 23818167 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A TRIAL IMPLANT PROCEDURE FOR THE EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PATIENT REPORTED PAIN IN THEIR LEFT LOWER LIMB. THE LEADS WERE REMOVED, AND A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED. NO ANOMALIES WERE DETECTED IN THE MRI SCAN AND THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED. THREE (3) DAYS LATER, THE PATIENT REPORTED THEIR SYMPTOM HAD RESOLVED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Limb Pain

  MAUDE report 23818047 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED SEVERE PAIN AND IMPAIRED MOBILITY A DAY AFTER THE TRIAL IMPLANT PROCEDURE. EVALUATION IN THE EMERGENCY DEPARTMENT IDENTIFIED A HEMATOMA. THE TRIAL LEADS WERE REMOVED, AND THE PATIENT WAS HOSPITALIZED. A MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED. THE PHYSICIAN DID NOT OBSERVE ANY FACTORS DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT, AND A DURAL PUNCTURE WAS NOT SUSPECTED. THE REPORTED EVENT PERSISTED FOLLOWING THE REMOVAL OF TRIAL LEADS.

  Patient problems: Hematoma; Pain; Paresis

  MAUDE report 23605150 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED SEVERE PAIN AND IMPAIRED MOBILITY A DAY AFTER THE TRIAL IMPLANT PROCEDURE. EVALUATION IN THE EMERGENCY DEPARTMENT IDENTIFIED A HEMATOMA. THE TRIAL LEADS WERE REMOVED, AND THE PATIENT WAS HOSPITALIZED. A MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED. THE PHYSICIAN DID NOT OBSERVE ANY FACTORS DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT, AND A DURAL PUNCTURE WAS NOT SUSPECTED. THE REPORTED EVENT PERSISTED FOLLOWING THE REMOVAL OF TRIAL LEADS.

  Patient problems: Hematoma; Pain; Paresis

  MAUDE report 23605149 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A NEW PAIN IN THEIR LOWER LEFT LIMB A DAY AFTER THE IMPLANT PROCEDURE FOR TRIAL EVOKE SCS SYSTEM. THE PHYSICIAN SUSPECTED A NERVE AGITATION MAY HAVE OCCURRED DURING LEAD IMPLANTATION, POTENTIALLY CONTRIBUTING TO THE REPORTED EVENT. PAIN MEDICATIONS WERE PRESCRIBED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Limb Pain

  MAUDE report 23303833 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH A TRIAL EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A NEW PAIN IN THEIR LOWER LEFT LIMB A DAY AFTER THE IMPLANT PROCEDURE FOR TRIAL EVOKE SCS SYSTEM. THE PHYSICIAN SUSPECTED A NERVE AGITATION MAY HAVE OCCURRED DURING LEAD IMPLANTATION, POTENTIALLY CONTRIBUTING TO THE REPORTED EVENT. PAIN MEDICATIONS WERE PRESCRIBED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Limb Pain

  MAUDE report 23303688 ↗
• InjuryAug 28, 2025Failure to Deliver Shock/Stimulation; Migration; Failure to Deliver Shock/Stimulation; Migration

  DURING THE TRIAL PERIOD OF AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM,THE PATIENT WAS EVALUATED FOR LOSS OF STIMULATION AND BLEEDING AT THE LEAD IMPLANT SITE. THE DRESSINGS WERE CHANGED AND THE IMPLANTING PHYSICIAN ADMINISTERED LOCALISED STEROID INJECTIONS. AN X-RAY WAS OBTAINED AND CONFIRMED LEAD MIGRATION. THE PATIENT¿S TRIAL LEADS WERE REMOVED THE FOLLOWING DAY. SIX (6) DAYS AFTER REMOVAL OF THE EVOKE SCS TRIAL LEADS, THE PATIENT WAS EVALUATED IN A HOSPITAL SETTING FOR LOSS OF CONSCIOUSNESS, INCONTINENCE AND LOWER LIMB WEAKNESS. THE PATIENT WAS SUBSEQUENTLY DISCHARGED WITH ALL SYMPTOMS RESOLVED EXCEPT RESIDUAL LOWER LIMB WEAKNESS. THE PATIENT IS UNDERGOING PHYSICAL THERAPY TO RESOLVE THE PERSISTING SYMPTOM. IT WAS CONFIRMED THAT THESE SYMPTOMS WERE NOT PRESENT DURING THE EVOKE SCS SYSTEM TRIAL PERIOD AND THAT ALL TRIAL EVOKE SCS SYSTEM DEVICES WERE EXPLANTED WHEN THESE SYMPTOMS BEGAN. THE IMPLANTING PHYSICIAN HAS NOT PROVIDED AN ASSESSMENT OF THE SYMPTOMS WHICH ONSET FOLLOWING THE EVOKE SCS SYSTEM TRIAL PERIOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Incontinence; Muscle Weakness/Atrophy; Pain; Syncope/Fainting

  MAUDE report 22911361 ↗