NA
Report
- Report Number
- 3006630150-2026-00046
- Event Type
- Injury
- Date Received
- January 5, 2026
- Date of Event
- December 11, 2025
- Report Date
- May 15, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729760542
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: PRO CODE (PRODUCT CODE): QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION; UPN: M365SC3138250; MODEL: SC-3138-25; SERIAL: (B)(6); BATCH: 7073698; UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION; UPN: M365SC43180; MODEL: SC-4318; BATCH: 20911813; UDI: (B)(4).
BLOCK D2B: PRO CODE (PRODUCT CODE): QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6) BATCH: 7073698. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318 BATCH: 20911813 UDI: (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: (B)(4). MODEL: SC-1232. SERIAL: (B)(6) BATCH: 793200 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6), BATCH: 21442766 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4). MODEL: SC-2218-70 SERIAL: (B)(6) BATCH: 21442766 UDI: (B)(4).
IT WAS REPORTED THAT THE PATIENT DEVELOPED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. SYMPTOMS OF DISCHARGE AT SITE WERE NOTED. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. PATIENT IS RECOVERING. THE EXPLANTED DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE PATIENT DEVELOPED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. SYMPTOMS OF DISCHARGE AT SITE WERE NOTED. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. PATIENT IS RECOVERING. THE EXPLANTED DEVICE WAS NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540395 | NA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-3138-25 | 7074723 | 08714729760542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Male | Required Intervention |