FDA Adverse Event
Death
Summary report: N
PRECISION®
MDR report key: 2495674
·
Received March 19, 2012
Report
- Report Number
- 3006630150-2012-00525
- Event Type
- Death
- Date Received
- March 19, 2012
- Date of Event
- February 24, 2012
- Report Date
- February 24, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD PASSED AWAY, CAUSE OF DEATH IS NOT KNOWN.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-8120-70 SERIAL # (B)(4) DESCRIPTION: ARTISAN 2X8 LIM, 70CM.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON THE PATIENT WAS ORIGINALLY SCHEDULED FOR EXPLANT WAS DUE TO INADEQUATE PAIN RELIEF. THERE WAS NO DEVICE FAILURE OR DEVICE INVOLVEMENT IN THE PATIENT'S DEATH. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF DEATH.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |