FDA Adverse Event
Death
Summary report: N
PRECISION
MDR report key: 1710469
·
Received June 3, 2010
Report
- Report Number
- 3006630150-2010-00919
- Event Type
- Death
- Date Received
- June 3, 2010
- Date of Event
- May 7, 2010
- Report Date
- May 7, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A TRIAL PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A POSSIBLE INFECTION AT THE LEAD SITE. THE PATIENT LATER PASSED AWAY AT THE HOSPITAL. THE PHYSICIAN DOES NOT HAVE A CONFIRMATION ON THE CAUSE OF DEATH, BUT DOES NOT BELIEVE THAT IT WAS DEVICE RELATED. THE PHYSICIAN STATED THAT THE PATIENT WAS ELDERLY, NOT IN GOOD HEALTH, FEBRILE AND EXHIBITING SYMPTOMS OF NAUSEA AND VOMITING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50T | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Death| H | (B) (4)| MODEL#: SC-2218-50E| ENH ST TRIAL LEAD KIT, |