FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 4889624
·
Received July 2, 2015
Report
- Report Number
- 3006630150-2015-01673
- Event Type
- Injury
- Date Received
- July 2, 2015
- Date of Event
- June 11, 2015
- Report Date
- June 11, 2015
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NO LONGER EXPERIENCING HEADACHE AND WAS REPORTEDLY DOING WELL.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2316-50, SERIAL #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD KIT-50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE, THE PATIENT HAD A DURA PUNCTURE AND WAS EXPERIENCING A HEADACHE POSTOPERATIVELY. THE PATIENT WAS TREATED WITH A BLOOD PATCH.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE, THE PATIENT HAD A DURA PUNCTURE AND WAS EXPERIENCING A HEADACHE POSTOPERATIVELY. THE PATIENT WAS TREATED WITH A BLOOD PATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430234 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2316-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |