FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1760734
·
Received July 15, 2010
Report
- Report Number
- 3006630150-2010-01206
- Event Type
- Injury
- Date Received
- July 15, 2010
- Date of Event
- June 18, 2010
- Report Date
- June 22, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORP
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PT WAS ADMITTED TO THE ER, BECAUSE SHE WAS EXPERIENCING A FEVER. THE PHYSICIAN BELIEVED THAT THE PT HAD AN INFECTION BASED ON LOW WHITE BLOOD COUNT. THE INFECTION WAS SYSTEM, AND IT WAS NOT LOCATED AT THE IPG OR LEAD SITE. THE PT WAS TREATED WITH A HIGH DOSE OF IV ANTIBIOTICS AND IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORP | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention | ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| SERIAL #: (B)(4)| SERIAL #: (B)(4)| MODEL #: SC-2218-50, |