FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 10810208
·
Received November 9, 2020
Report
- Report Number
- 3006630150-2020-05433
- Event Type
- Injury
- Date Received
- November 9, 2020
- Date of Event
- October 18, 2020
- Report Date
- November 9, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729784067
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50E, SERIAL: (B)(4), BATCH: 7081418.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEIZURE LIKE SYMPTOMS. INADEQUATE STIMULATION WAS ALSO REPORTED. THE TRIAL LEADS WERE PULLED OUT AND WERE NOT RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1278132 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50E | 7081380 | 08714729784067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |