FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3192646
·
Received June 27, 2013
Report
- Report Number
- 3006630150-2013-01324
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 12, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT OF DYSPNEA WAS NOT RELATED TO THE DEVICE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A DEVICE RELATED EVENT OF DYSPNEA. THE PATIENT WAS REPROGRAMMED AND HIS MEDICATION WAS CHANGED. THE EVENT HAS RESOLVED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A DEVICE RELATED EVENT OF DYSPNEA. THE PATIENT WAS REPROGRAMMED AND HIS MEDICATION WAS CHANGED. THE EVENT HAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292617 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |