LINEAR ST
Report
- Report Number
- 3006630150-2024-02598
- Event Type
- Injury
- Date Received
- April 24, 2024
- Date of Event
- March 30, 2024
- Report Date
- September 22, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14160. MODEL: SC-1416. SERIAL: (B)(6). BATCH: 222854.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7141019.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14160. MODEL: SC-1416. SERIAL: (B)(6). BATCH: 222854.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AND WEAKNESS IN THE LEGS FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED TO THE HOSPITAL. A MAGNETIC RESONANCE IMAGING (MRI) WAS DONE, AND HEMATOMA WAS CONFIRMED. THE PHYSICIAN BELIEVED THAT THE HEMATOMA WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND ALL DEVICE COMPONENTS WERE REMOVED AND DISCARDED BY THE MEDICAL FACILITY.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AND WEAKNESS IN THE LEGS FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED TO THE HOSPITAL. A MAGNETIC RESONANCE IMAGING (MRI) WAS DONE, AND HEMATOMA WAS CONFIRMED. THE PHYSICIAN BELIEVED THAT THE HEMATOMA WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND ALL DEVICE COMPONENTS WERE REMOVED AND DISCARDED BY THE MEDICAL FACILITY.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AND WEAKNESS IN THE LEGS FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMITTED TO THE HOSPITAL. A MAGNETIC RESONANCE IMAGING (MRI) WAS DONE, AND HEMATOMA WAS CONFIRMED. THE PHYSICIAN BELIEVED THAT THE HEMATOMA WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AND ALL DEVICE COMPONENTS WERE REMOVED AND DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1427625 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7139840 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Required Intervention |