FDA Adverse Event
Death
Summary report: N
PRECISION®
MDR report key: 2240879
·
Received September 9, 2011
Report
- Report Number
- 3006630150-2011-01438
- Event Type
- Death
- Date Received
- September 9, 2011
- Date of Event
- August 11, 2011
- Report Date
- August 11, 2011
- 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-2218-50 (B)(4) MODEL DESCRIPTION:ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOESN'T BELIEVE THAT THE PATIENT'S DEATH IS DEVICE RELATED AS PATIENT HAD OTHER HEALTH PROBLEMS. NO ADDITIONAL INFORMATION WILL BE AVAILABLE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS DECEASED. NO FURTHER INFORMATION WAS RECEIVED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS DECEASED. NO FURTHER INFORMATION WAS RECEIVED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS DECEASED. NO FURTHER INFORMATION WAS RECEIVED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS DECEASED. NO FURTHER INFORMATION WAS RECEIVED.
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 |