FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2801988
·
Received October 23, 2012
Report
- Report Number
- 3006630150-2012-01932
- Event Type
- Injury
- Date Received
- October 23, 2012
- Date of Event
- September 19, 2012
- Report Date
- October 1, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #S: (B)(4), DESCRIPTION: LINEAR ST- LEAD, 50CM. EXPLANTED IPG AND LEADS WILL NOT BE RETURNED TO BSN AS IT WAS DISCARDED BY MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO DISCOMFORT AT THE IPG POCKET SITE. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |