FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA®
MDR report key: 6169461
·
Received December 13, 2016
Report
- Report Number
- 3006630150-2016-03643
- Event Type
- Injury
- Date Received
- December 13, 2016
- Date of Event
- November 18, 2016
- Report Date
- November 21, 2016
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION PROCEDURE DUE TO PAIN AT POCKET SITE.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT. IT WAS NOTED THE PATIENT HAD SWELLING AROUND LEAD SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT. IT WAS NOTED THE PATIENT HAD SWELLING AROUND LEAD SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AND DISCOMFORT. IT WAS NOTED THE PATIENT HAD SWELLING AROUND LEAD SITE. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821460 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |