LINEAR? ST
Report
- Report Number
- 3006630150-2025-10131
- Event Type
- Injury
- Date Received
- November 7, 2025
- Date of Event
- October 16, 2025
- Report Date
- March 4, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC12320; MODEL: SC-1232; SERIAL: (B)(6); BATCH: 772139; UDI: (B)(4).
INVESTIGATION RESULTS: THE IPG AND LEADS WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORDS: IT WAS CONFIRMED THAT THE DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: THERE IS NO COMPLAINT AGAINST THE FUNCTIONALITY OF THE DEVICE AND THE COMPLAINT AS REPORTED COULD NOT BE CONFIRMED. RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT AND THE CONCLUSION CODE UNABLE TO EXCLUDE DEVICE PROBLEM WILL BE USED.
IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) LEADS WERE CONSUMING EXCESSIVE ENERGY. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.
IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) LEADS WERE CONSUMING EXCESSIVE ENERGY. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS FREQUENTLY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO EXCESSIVE ENERGY CONSUMPTION OF THE SPINAL CORD STIMULATOR (SCS) LEADS. THE IPG WAS REPLACED ALONG WITH THE LEADS AND WILL NOT BE RETURNED.
IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) LEADS WERE CONSUMING EXCESSIVE ENERGY. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS FREQUENTLY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO EXCESSIVE ENERGY CONSUMPTION OF THE SPINAL CORD STIMULATOR (SCS) LEADS. THE IPG WAS REPLACED ALONG WITH THE LEADS AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1923995 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7155020 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Male | Required Intervention |