FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 15411016
·
Received September 13, 2022
Report
- Report Number
- 3006630150-2022-04711
- Event Type
- Injury
- Date Received
- September 13, 2022
- Date of Event
- August 19, 2019
- Report Date
- September 13, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED FEW YEARS AGO BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: PROCEDURE HAPPENED FEW YEARS AGO.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2579052 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | 20616317 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention |