FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3103616
·
Received May 9, 2013
Report
- Report Number
- 3006630150-2013-00924
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- November 30, 2012
- Report Date
- November 30, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT FELT WARMTH AT THE POCKET SITE DURING CHARGING. DATABASE ANALYSIS REVEALED THAT THE DEVICE APPEARED TO BE WORKING AS EXPECTED. THE PATIENT WAS GIVEN WITH STEROID INJECTION. THE PHYSICIAN HAD RECOMMENDED AN EXPLANT PROCEDURE. THE PATIENT WILL NOT HAVE THE EXPLANT PROCEDURE AT THIS TIME DUE TO NONDEVICE RELATED ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203274 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |