FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 4221718
·
Received November 3, 2014
Report
- Report Number
- 3006630150-2014-02559
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- October 13, 2014
- Report Date
- October 13, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD DISCOMFORT AT THE POCKET SITE. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702606 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |