FDA Adverse Event
Death
Summary report: N
PRECISION®
MDR report key: 2859087
·
Received December 5, 2012
Report
- Report Number
- 3006630150-2012-02259
- Event Type
- Death
- Date Received
- December 5, 2012
- Date of Event
- November 19, 2012
- Report Date
- November 19, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DATE OF DEATH IS UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #:SC-8216-50 SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED FROM THE NURSE THAT THE PATIENT PASSED AWAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
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 | 50 YR | Death |