FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1841514
·
Received September 14, 2010
Report
- Report Number
- 3006630150-2010-01581
- Event Type
- Injury
- Date Received
- September 14, 2010
- Date of Event
- August 16, 2010
- Report Date
- August 16, 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
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEFT SIDE OF HER LEADS. THE PATIENT ALSO REPORTED A LUMP IN THE SAME AREA. THE BSN SALES REPRESENTATIVE REPORTED THAT A REVISION WILL TAKE PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IPG KIT (WITHOUT PULL - THROUGH TUNNELER)| MODEL # SC-2218-50, SERIAL # (B)(4)| MODEL # SC-1110-02, SERIAL # (B)(4)| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET |