FDA Adverse Event
Death
Summary report: N
PRECISION®
MDR report key: 2265581
·
Received September 27, 2011
Report
- Report Number
- 3006630150-2011-01482
- Event Type
- Death
- Date Received
- September 27, 2011
- Date of Event
- August 21, 2011
- Report Date
- September 2, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-8216-50, (B)(4), MODEL DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (LIM), 50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD DIED. NO FURTHER INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD DIED. NO FURTHER INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD DIED. NO FURTHER INFORMATION WAS PROVIDED.
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 | 62 YR | Death |