LINEAR? 3-4
Report
- Report Number
- 3006630150-2025-05353
- Event Type
- Injury
- Date Received
- July 10, 2025
- Date of Event
- April 22, 2025
- Report Date
- January 19, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729789581
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7083421, UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138350 MODEL: SC-3138-35 SERIAL: (B)(6) BATCH: 7087641 UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION, UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH: 7087556, UDI: (B)(4).
CORRECTION TO THE SUPPLEMENTAL MDR IN H6. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 7083421, UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH: 7087641, UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138350, MODEL: SC-3138-35, SERIAL: (B)(6), BATCH: 7087556, UDI: (B)(4).
B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7083421. UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7087641. UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7087556. UDI: (B)(4).
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THESE SCS DEVICES WERE REPLACED DUE TO MIGRATION, WHICH WAS CONFIRMED THROUGH X-RAY IMAGING. AS A RESULT, THE PATIENT NO LONGER EXPERIENCED THERAPEUTIC RELIEF. THE PATIENT UNDERWENT A LEADS REVISION PROCEDURE WHEREIN THEIR LEADS WERE EXPLANTED AND REPLACED. THE LEADS WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. THE PATIENT REPORTED PROCEDURAL PAIN IN THE IMMEDIATE POSTOPERATIVE PERIOD, WHICH APPEARED TO OVERSHADOW THE PATIENT'S PERCEPTION OF CHRONIC PAIN SYMPTOMS.
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THESE SCS DEVICES WERE REPLACED DUE TO MIGRATION, WHICH WAS CONFIRMED THROUGH X-RAY IMAGING. AS A RESULT, THE PATIENT NO LONGER EXPERIENCED THERAPEUTIC RELIEF. THE PATIENT UNDERWENT A LEADS REVISION PROCEDURE WHEREIN THEIR LEADS WERE EXPLANTED AND REPLACED. THE LEADS WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. THE PATIENT REPORTED PROCEDURAL PAIN IN THE IMMEDIATE POSTOPERATIVE PERIOD, WHICH APPEARED TO OVERSHADOW THE PATIENT'S PERCEPTION OF CHRONIC PAIN SYMPTOMS.
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410429 | LINEAR? 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2352-70 | 7083424 | 08714729789581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female | Required Intervention |