FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1212636
·
Received October 24, 2008
Report
- Report Number
- 2029203-2008-00840
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 26, 2008
- Report Date
- September 26, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A COMPLAINT WAS REPORTED REGARDING INFECTION AT THE POCKET SITE. THE PATIENT'S POCKET SITE HAD SEEPED THEREFORE, ALLOWING THE AREA TO BECOME INFECTED. THE PRECISION SYSTEM WAS EXPLANTED AND DISCARDED AND THE LEADS WERE LEFT IN. IN ADDITION, TWO EXTENSIONS WERE IMPLANTED TO KEEP THE ENDS OF THE LEADS SAFE. THE POCKET SITE WAS DEBRIDED AND AN A ONE GRAM ANTIBIOTIC WAS IMPLANTED INTO THE POCKET SITE. NO CULTURE WAS TAKEN AND THE PATIENT IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | AN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES)| MODEL # SC-8120-50 |