LINEAR? ST
Report
- Report Number
- 3006630150-2026-00869
- Event Type
- Injury
- Date Received
- February 12, 2026
- Date of Event
- December 29, 2025
- Report Date
- May 14, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729784067
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: EXACT DATE UNKNOWN, DATE OF LEAD PULL WAS USED AS EVENT OCCURRED POST-TRIAL. INVESTIGATION RESULTS. THE DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE PHYSICIAN CONFIRMED THAT INFECTION WAS NOT PROCEDURE RELATED AND UNKNOWN IF IT WAS RELATED TO THE DEVICE. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND WAS STABLE UPON FOLLOW-UP. THE REMOVED LEADS WERE NOT RETURNED. DEVICE HISTORY RECORD. IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC221850E0 MODEL: SC-2218-50E SERIAL: (B)(6). BATCH: 7173196 UDI: (B)(4).
BLOCK B3: EXACT DATE UNKNOWN, DATE OF LEAD PULL WAS USED AS EVENT OCCURRED POST-TRIAL.
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AROUND THE LEAD INSERTION SITE FOLLOWING THE TRIAL PROCEDURE. THE PHYSICIAN CONFIRMED THAT INFECTION WAS NOT PROCEDURE RELATED AND UNKNOWN IF IT WAS RELATED TO THE DEVICE. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND WAS STABLE UPON FOLLOW-UP. THE REMOVED LEADS WERE NOT RETURNED.
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AROUND THE LEAD INSERTION SITE FOLLOWING THE TRIAL PROCEDURE. THE PHYSICIAN CONFIRMED THAT INFECTION WAS NOT PROCEDURE RELATED AND UNKNOWN IF IT WAS RELATED TO THE DEVICE. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND WAS STABLE UPON FOLLOW-UP. THE REMOVED LEADS WERE NOT RETURNED.
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AROUND THE LEAD INSERTION SITE FOLLOWING THE TRIAL PROCEDURE. THE PHYSICIAN CONFIRMED THAT INFECTION WAS NOT PROCEDURE RELATED AND UNKNOWN IF IT WAS RELATED TO THE DEVICE. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND WAS STABLE UPON FOLLOW-UP. THE REMOVED LEADS WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35971 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50E | 7166999 | 08714729784067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |