FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA®
MDR report key: 3924061
·
Received July 9, 2014
Report
- Report Number
- 3006630150-2014-01558
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 16, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399550 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |