FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA®
MDR report key: 6202337
·
Received December 23, 2016
Report
- Report Number
- 3006630150-2016-03832
- Event Type
- Injury
- Date Received
- December 23, 2016
- Date of Event
- December 9, 2016
- Report Date
- December 12, 2016
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION AT THIS TIME.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN. IT WAS ALSO NOTED THAT THE STIMULATOR WAS NOT CHARGING AND HAD TO CHARGE FREQUENTLY. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN. IT WAS ALSO NOTED THAT THE STIMULATOR WAS NOT CHARGING AND HAD TO CHARGE FREQUENTLY. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 851751 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |