PRECISION®
Report
- Report Number
- 3006630150-2014-02134
- Event Type
- Injury
- Date Received
- September 18, 2014
- Report Date
- June 5, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
DATE RECEIVED BY MFR: SHOULD HAVE BEEN 03-SEP-2014.
DATE OF EVENT: (B)(6) 2013.
ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION AT THIS TIME.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT, BURNING AND STINGING SENSATION WITH STIMULATION. THE IPG WAS PROTRUDING AND LYING IN A VERTICAL PLANE TO THE SKIN. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE IPG WILL BE REPOSITIONED.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT, BURNING AND STINGING SENSATION WITH STIMULATION. THE IPG WAS PROTRUDING AND LYING IN A VERTICAL PLANE TO THE SKIN. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE IPG WILL BE REPOSITIONED.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT, BURNING AND STINGING SENSATION WITH STIMULATION. THE IPG WAS PROTRUDING AND LYING IN A VERTICAL PLANE TO THE SKIN. THE PATIENT WILL UNDERGO A REVISION PROCEDURE WHEREIN THE IPG WILL BE REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580387 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |