FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2162873
·
Received July 15, 2011
Report
- Report Number
- 3006630150-2011-01080
- Event Type
- Injury
- Date Received
- July 15, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2352-50, (B)(4), DESCRIPTION: LINEAR 3-4 LEAD 50CM.
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING PAIN AT HER POCKET SITE. THE PATIENT WAS REPROGRAMMED; HOWEVER WAS NOT ABLE TO GET PROPER STIMULATION. THE PATIENT WILL UNDERGO AN EXPLANT DUE TO POCKET DISCOMFORT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING PAIN AT HER POCKET SITE. THE PATIENT WAS REPROGRAMMED HOWEVER WAS NOT ABLE TO GET PROPER STIMULATION. THE PATIENT WILL UNDERGO AN EXPLANT DUE TO POCKET DISCOMFORT.
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 | 57 YR | Required Intervention |