FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 9979084
·
Received April 20, 2020
Report
- Report Number
- 3006630150-2020-01821
- Event Type
- Injury
- Date Received
- April 20, 2020
- Date of Event
- January 1, 2013
- Report Date
- April 20, 2020
- 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
THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2013 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: (B)(6) 2013. MODEL NUMBER/CATALOG NUMBER: SC-2138-70, SERIAL NUMBER: (B)(4) BATCH/LOT NUMBER: 140270/140455, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAAD 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441852 | PRECISION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | 163356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |