FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3143534
·
Received June 3, 2013
Report
- Report Number
- 3006630150-2013-01142
- Event Type
- Injury
- Date Received
- June 3, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 13, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION CANNOT BE OBTAINED REGARDING EXPLANT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S LEADS WERE COMING OUT OF THE SKIN AND THERE WAS AN ACTUAL BREAKAGE OF THE SKIN. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S LEADS WERE COMING OUT OF THE SKIN AND THERE WAS AN ACTUAL BREAKAGE OF THE SKIN. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243508 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |