FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 4330725
·
Received December 15, 2014
Report
- Report Number
- 3006630150-2014-03041
- Event Type
- Injury
- Date Received
- December 15, 2014
- Date of Event
- October 30, 2014
- Report Date
- November 20, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-3138-25, SERIAL#: (B)(4), DESCRIPTION: SCS PHI EXT 35 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A SEVERE POST OPERATIVE HEADACHE DUE TO DURAL PUNCTURE WITH CSF LEAKAGE. THE PATIENT WAS HOSPITALIZED AND ADMINISTERED PAIN AND ANTI-NAUSEA MEDICATION AS WELL AS OXYGEN TREATMENTS. THE PATIENT'S HEADACHE RESOLVED AND THE PATIENT WAS DISCHARGED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED A SEVERE POST OPERATIVE HEADACHE DUE TO DURAL PUNCTURE WITH CSF LEAKAGE. THE PATIENT WAS HOSPITALIZED AND ADMINISTERED PAIN AND ANTI-NAUSEA MEDICATION AS WELL AS OXYGEN TREATMENTS. THE PATIENT'S HEADACHE RESOLVED AND THE PATIENT WAS DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821343 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2366-30 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| R |