ALTIUS SYSTEM
Report
- Report Number
- 3026283936-2025-00006
- Event Type
- Malfunction
- Date Received
- March 31, 2025
- Date of Event
- September 30, 2025
- Report Date
- November 12, 2025
- Manufacturer
- NEUROS MEDICAL INC.
- Product Code
- SAZ
- PMA / PMN Number
- P230020
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
CUFF LEAD S/N (B)(6) - THE IS-1 CONNECTOR SHOWED AN OPEN CIRCUIT FOR BOTH PIN AND RING LEAD WIRES AND FAILED CONTINUITY TESTING. PIN AND RING LEAD WIRES ARE BROKEN AT THE END OF THE EPOXY BACKFILL STEM OF THE JOINT. IS-1 CONNECTOR WAS BENT AND WHEN TESTED IT SHOWED NO CONTINUITY DUE TO BROKEN PIN AND RING WIRES AT EPOXY. THE NERVE CUFF ELECTRODE (LEAD) INVOLVED IN THIS EVENT, WAS UTILIZED UNDER IDE G130203 (SUBJECT OF THE QUEST CLINICAL STUDY) AND IS NOT THE APPROVED ALTIUS SYSTEM NERVE CUFF ELECTRODE (P230020/08-26-2024). NEUROS IS SUBMITTING THIS REPORT IN COMPLIANCE WITH FDA MEDICAL DEVICE REPORTING REGULATIONS UNDER 21 CFR PART 803.
ALTHOUGH THE PRODUCT WILL NOT BE RETURNED AT THIS TIME FOR INVESTIGATION, IMPEDANCE MEASUREMENTS, REPORTED PATIENT SYMPTOMS AND HISTORICAL DEVICE KNOWLEDGE SUGGEST THAT A MECHANICAL BREAK OF THE NERVE CUFF ELECTRODE (LEAD) IS THE MOST LIKELY CAUSE. THE NERVE CUFF ELECTRODE (LEAD) INVOLVED IN THIS EVENT, WAS UTILIZED UNDER IDE G130203 (SUBJECT OF THE QUEST CLINICAL STUDY) AND IS NOT THE APPROVED ALTIUS SYSTEM NERVE CUFF ELECTRODE (P230020/08-26-2024). NEUROS IS SUBMITTING THIS REPORT IN COMPLIANCE WITH FDA MEDICAL DEVICE REPORTING REGULATIONS UNDER 21 CFR PART 803.
ALTHOUGH THE PRODUCT WILL NOT BE RETURNED AT THIS TIME FOR INVESTIGATION, IMPEDANCE MEASUREMENTS, REPORTED PATIENT SYMPTOMS AND HISTORICAL DEVICE KNOWLEDGE SUGGEST THAT A MECHANICAL BREAK OF THE NERVE CUFF ELECTRODE (LEAD) IS THE MOST LIKELY CAUSE. THE NERVE CUFF ELECTRODE (LEAD) INVOLVED IN THIS EVENT, WAS UTILIZED UNDER IDE (B)(4) (SUBJECT OF THE QUEST CLINICAL STUDY) AND IS NOT THE APPROVED ALTIUS SYSTEM NERVE CUFF ELECTRODE (P230020/08-26-2024). NEUROS IS SUBMITTING THIS REPORT IN COMPLIANCE WITH FDA MEDICAL DEVICE REPORTING REGULATIONS UNDER 21 CFR PART 803.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR AND LEAD FOR PAIN MANAGEMENT CAUSED BY BELOW-KNEE AMPUTATION. IT WAS REPORTED THAT THEIR DEVICE WAS CAUSING A STRONG SHOCKING SENSATION WHEN RUNNING THERAPY SESSIONS AT HOME. THE PATIENT ALSO EXPERIENCED PAIN AND DISCOMFORT AS A RESULT OF THE SHOCK, EVEN REPORTING FALLING OUT OF A CHAIR DUE TO SUCH DISCOMFORT. THIS PATIENT WAS ENROLLED IN THE QUEST TRIAL, NOW COMPLETED, AND CAME INTO THE HEALTH CARE FACILITY AT THE YEAR-6 ANNUAL LONG-TERM FOLLOW-UP VISIT. THE SHOCKING SENSATION IS EXPERIENCED ONLY DURING THERAPY SESSIONS AND IS INTERMITTENT WITH NORMALLY EXPECTED THERAPY-INDUCED SENSATION. AS AN IMMEDIATE REMEDIAL MEASURE, THE THERAPY STRENGTH WAS SIGNIFICANTLY LOWERED FROM THE CURRENT SETTINGS TO MINIMIZE THE DISCOMFORT DURING THERAPY SESSIONS. FOLLOW-UP (B)(6) 2025 - ANOTHER COMPLAINT OF SHOCKING SENSATION WAS SUBMITTED BY THE SUBJECT THROUGH THE COMPANY WEBSITE. THE CLINICAL SITE LOST THE SURGEON AND HAS IDENTIFIED A NEW ONE. THIS EXPLANT WILL BE SCHEDULED AS SOON AS POSSIBLE. FOLLOW-UP (B)(6) 2025 CONFIRMED THE CLINICAL SITE PERFORMED AN EXPLANT OF THE ALTIUS SYSTEM. THE PROCEDURE WAS SUCCESSFUL WITH NO CLINICAL SEQUELA REPORTED. CUFF LED S/N (B)(6) - THE IS-1 CONNECTOR SHOWED AN OPEN CIRCUIT FOR BOTH PIN AND RING LEAD WIRES AND FAILED CONTINUITY TESTING. PIN AND RING LEAD WIRES ARE BROKEN AT THE END OF THE EPOXY BACKFILL STEM OF THE JOINT. IS-1 CONNECTOR WAS BENT AND WHEN TESTED IT SHOWED NO CONTINUITY DUE TO BROKEN PIN AND RING WIRES AT EPOXY.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR AND LEAD FOR PAIN MANAGEMENT CAUSED BY BELOW-KNEE AMPUTATION. IT WAS REPORTED THAT THEIR DEVICE WAS CAUSING A STRONG SHOCKING SENSATION WHEN RUNNING THERAPY SESSIONS AT HOME. THE PATIENT ALSO EXPERIENCED PAIN AND DISCOMFORT AS A RESULT OF THE SHOCK, EVEN REPORTING FALLING OUT OF A CHAIR DUE TO SUCH DISCOMFORT. THIS PATIENT WAS ENROLLED IN THE QUEST TRIAL, NOW COMPLETED, AND CAME INTO THE HEALTH CARE FACILITY AT THE YEAR-6 ANNUAL LONG-TERM FOLLOW-UP VISIT. THE SHOCKING SENSATION IS EXPERIENCED ONLY DURING THERAPY SESSIONS AND IS INTERMITTENT WITH NORMALLY EXPECTED THERAPY-INDUCED SENSATION. AS AN IMMEDIATE REMEDIAL MEASURE, THE THERAPY STRENGTH WAS SIGNIFICANTLY LOWERED FROM THE CURRENT SETTINGS TO MINIMIZE THE DISCOMFORT DURING THERAPY SESSIONS.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR AND LEAD FOR PAIN MANAGEMENT CAUSED BY BELOW-KNEE AMPUTATION. IT WAS REPORTED THAT THEIR DEVICE WAS CAUSING A STRONG SHOCKING SENSATION WHEN RUNNING THERAPY SESSIONS AT HOME. THE PATIENT ALSO EXPERIENCED PAIN AND DISCOMFORT AS A RESULT OF THE SHOCK, EVEN REPORTING FALLING OUT OF A CHAIR DUE TO SUCH DISCOMFORT. THIS PATIENT WAS ENROLLED IN THE QUEST TRIAL, NOW COMPLETED, AND CAME INTO THE HEALTH CARE FACILITY AT THE YEAR-6 ANNUAL LONG-TERM FOLLOW-UP VISIT. THE SHOCKING SENSATION IS EXPERIENCED ONLY DURING THERAPY SESSIONS AND IS INTERMITTENT WITH NORMALLY EXPECTED THERAPY-INDUCED SENSATION. AS AN IMMEDIATE REMEDIAL MEASURE, THE THERAPY STRENGTH WAS SIGNIFICANTLY LOWERED FROM THE CURRENT SETTINGS TO MINIMIZE THE DISCOMFORT DURING THERAPY SESSIONS. FOLLOW-UP (B)(6) 2025 - ANOTHER COMPLAINT OF SHOCKING SENSATION WAS SUBMITTED BY THE SUBJECT THROUGH THE COMPANY WEBSITE. THE CLINICAL SITE LOST THE SURGEON AND HAS IDENTIFIED A NEW ONE. THIS EXPLANT WILL BE SCHEDULED AS SOON AS POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1166254 | ALTIUS SYSTEM | NERVE CUFF ELECTRODE | SAZ | NEUROS MEDICAL INC. | FG-602-002 | 20020402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Other |