FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 11315145
·
Received February 11, 2021
Report
- Report Number
- 3006630150-2021-00427
- Event Type
- Injury
- Date Received
- February 11, 2021
- Date of Event
- May 1, 2020
- Report Date
- February 11, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. EXPLANT DATE: COUPLE OF MONTHS AGO FROM THE AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2208-50, SERIAL: (B)(4), BATCH: 195391/192274.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. ALL COMPONENTS WERE EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 211802 | PRECISION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | 177846 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |