FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2880451
·
Received December 19, 2012
Report
- Report Number
- 3006630150-2012-02425
- Event Type
- Injury
- Date Received
- December 19, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2158-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR LEAD WITH ENHANCED STYLET, 70CM MODEL #: SC-2352-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 70CM.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S LEADS WERE PROTRUDING THROUGH THE SKIN. IT WAS SEALED UP AND THE PATIENT IS REPORTEDLY DOING WELL.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S LEADS WERE PROTRUDING THROUGH THE SKIN. IT WAS SEALED UP AND THE PATIENT IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2158-70 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |