FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1884016
·
Received October 14, 2010
Report
- Report Number
- 3006630150-2010-01772
- Event Type
- Injury
- Date Received
- October 14, 2010
- Date of Event
- September 29, 2010
- Report Date
- September 29, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG DOCUMENTATION OF THE IMPLANTED IPG REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MFG. A REVIEW OF THE STERILIZATION DOCUMENTATION FOUND THEM TO BE SATISFACTORY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PT HAS SWELLING AT THE IPG SITE. THE PHYSICIAN AS A PRECAUTION AGAINST INFECTION WILL WASH OUT THE IPG SITE. THE PT UNDERWENT A SUCCESSFUL ANTIBIOTICS WASHOUT OF THE IPG POCKET SITE AND IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |