FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 9008474
·
Received September 12, 2019
Report
- Report Number
- 3006630150-2019-04998
- Event Type
- Injury
- Date Received
- September 12, 2019
- Date of Event
- August 26, 2017
- Report Date
- September 12, 2019
- 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
EVENT DATE: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2017 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. MODEL NUMBER/CATALOG NUMBER: SC-2138-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 141121/141488/151050, MODEL/CATALOG DESCRIPTION: PHASE III LINEAR LEAD - 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801763 | PRECISION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | 164397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |