FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1061325
·
Received June 13, 2008
Report
- Report Number
- 2029203-2008-00385
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 16, 2008
- Report Date
- May 16, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORP
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
SHORTLY AFTER A TRIAL IMPLANT PROCEDURE, THE PT REPORTED NAUSEA AND VOMITING. THE SURGEON BELIEVES THE ANTIBIOTICS PRESCRIBED TO PREVENT INFECTION DURING THE TRIAL MAY BE THE SOURCE OF THE REPORTED ISSUE. THE PT IS REPORTEDLY DOING BETTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR LEAD | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORP | SC-2208-70 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SC-2208-70 |