FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2992526
·
Received March 7, 2013
Report
- Report Number
- 3006630150-2013-00351
- Event Type
- Injury
- Date Received
- March 7, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 8, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION WILL BE PROVIDED TO BSN REGARDING THIS EVENT. THE IPG PASSED ALL VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS EXPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS EXPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS EXPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97419 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |