FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1864310
·
Received October 7, 2010
Report
- Report Number
- 3006630150-2010-01722
- Event Type
- Injury
- Date Received
- October 7, 2010
- Date of Event
- September 13, 2010
- Report Date
- September 13, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT DURING AN IMPLANT, THE PHYSICIAN HAD TO PERFORM A WET TAP DUE TO A DURA PUNCTURE. THE PT DEVELOPED A POSTURAL HEADACHE POST IMPLANT. THE PHYSICIAN REPORTED THAT THERE WAS NO RESISTANCE OR DIFFICULTY ENCOUNTERED DURING THE PROCEDURE. THE PT WAS REPORTEDLY DOING WELL FOLLOWING A BLOOD PATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R | ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| SERIAL #: (B)(4)| MODEL #: SC-2218-50, |